C6ng ty TNHH san xu~t & Thuong m~i Thi~t bi Y t~ Hoang San E)/C: VU N9i - Lien B~t - Lrng Hoa - TP. Ha N9i

HOANGSON co .. LTD E)T: 04 . 66842465 - mail: hoangsontbyt@gmail.com

HOSO GIA Y CHUNG NH~N DANG KY LU"U HANH sAN PHAM

vA GIA Y CHUNG NH~N D~T TIEU CHuAN

QuAN LY CHAT LUONG

Thang 06 n3m 201 7

Trong qua trinh IlfU hiuth san phk dan vi co trach nhi~m : In the product's circulation and business activities, it is required to strictly obey the following obligations:

I. Ch~p hiuth d&y dli cae quy dinh v~ quan Iy trang thi~t bi y t~ clia Vi~t Nam. Comply with the Vietnam regulations on management of medical devices.

2. Chiu trach nhi~m vi! eh~t luqng san phAm d8: dang ky va va hO(lt di)ng san xu~t kinh doanh tren thi tnrimg thea quy dinh cua phap lu~t Vi~t Nam. Have full responsibility on quality of the product registered and Company's operations on the market in accordance with the Vietnam laws.

3. Thong bao cho B(j Y t~ truoc 30 ngay trong cae tnrong hgp sau: inform to the Ministry of Health in advance (30 days) in thefoi/owing cases: - Thay dbi ten, dia chi (change in the name or address of the Company) - M9i Sl! thay dbi lien quan den san phAm (Any change of the registered product) - Tach, sap nh~p, dbi ten ho~c ch~m dirt hO(lt d(jng san xu~t kinh doanh (Separation, merger or termination of the Company's operations)

4. Gi~y chUng nhan nay co gia tri 03 eba) niim k~ tir ngay kyo Tnroc khi h~t h(lIl 30 eba muai) ngay, dan vi phili lilm thl! !\Ie xin gia h(ln dang kY neu vfu! ti~p t~c IlfU hiuth san ph~m tren. This certification is valid for three (03) years from the date of signing. Before its expiration date of thirty (30) days, it is required to renew the validity of certification if the product is continuing circulation in Vietnam.

TL. BO TRUONG VlJTRUONG

VlJ TRANG THIET Bl vA CONG TRiNH Y TE FORM~I HEALTH

DEPARTMENT OF M£'f5IC,q DEViq:s & CONSTRUCTION .,nf~€~' 0R \ ., /Z .. - - ···, , -,

1!;.'V7"" : _. ~\\~ "-:.' ~;: · ~·X .. r }'!'!~~

\ ~~t~~:, ,::E: ibj' ~~~~))~§n

CQNG HoA xA HQI CHU NGHIA VI.i):T NAM SOCIALIST REPUBLIC OF VIETNAM

I~ B-A-N-SA- O-',

BQYTE MINISTRY OF HEALTH

GIAy CHUNG NHAN •

DANG KY LU'U HANH SAN PHAM TRANG THIET BI Y TE T~I VI~T NAM .

CERTIFICATE

REGISTRATION FOR CIRCULATION OF MEDICAL DEVICES MANUFACTURING IN VIETNAM

BO Y TE s6 (No) 12015/BYT-TB-CT

Ha Ni?i, ngay (date):-1{ /1112015

DANG KY LU'U ~~~ ~~~~~~ ~!t~ THIET Bl Y TE SAN XUAT T~I VI~T NAAI

CERTIFICATE

REGISTRATION FOR CIRCULATION OF MEDICAL DEVICES MANUFACTURING IN VIETNAM

- Can Cll: Nghi dinh s6 63/20121NEl-CP ngay 31 thilng 8 nam 2012 cua Chinh phu quy dinh chllc nang, nhi~m V\l, quy~n h?ll va co cfru t6 ChtfC cua Bi? Y t~;

Pursuant to Decree No. 63120121ND-CP dated August 31", 2012 issued by Government stipulating the junctions, tasks, authority and

I" organizational str!'cture of the Ministry of Health;

- Can Cll Lu~t Chat lugng san phfun, hang hoa ngay 21 thang 11 nam 2007;

Pursuant toLaw on Quality of products and goods dated November 21",2007;

- Can cll Thong tu 56 07!20021TT-BYT ngay 30 thang 5 nam 2002 . cua Bi? Y t€ v~ hu6ng dful dang ky luu hilnh san phdm trang thi@t bi

I y t~. Pursuant to Circular No. 07120021TT-BYT dated May 30, 2002 of

the Ministry of Health on guiding for circulation registration of medical devices.

- Xcit h6 sO' va dan d~ nghi cfrp 56 dang ky luu hilnh siln phdm eua don vi.

i Having examination of documentation and application letter for circulation of medical device submitted by the applicant.

BQ Y TE CHUNG NH~N MINISTRY OF HEALTH CERTIFIES THAT

Nba san xu lit (Manufacturer): CONG TY TNHH SAN XUAT & THUONG M~I THIET B] Y TE HoANG SON

Dja chi (Address): Vii Ni?i - Lien B\lt - Dng Hoa -TP. Ha Ni?i.

ElUOC PHEP LUU HANH T ~I VItT NAM SAN PHAM

HAS A PERMISSION TO CIRCULATE THE FOLLOWING MEDICAL DEVICES IN VIETNAM

Tieu chu§n cong bAi San ph§mlProduct(s) Mil hi~u/Code I Conform to the

Standards of HS - HNOI I TC 2015iHSC - HN HS - CAOI I TC 2015iHSC - CA HS - OXYOI I TC 201 5iHSC - OC HS - OXY2NOI I TC 2015iHSC -HS - HDO I I TC 2015iHSV-HD

CHVNGTHVC BAN SAOf)(JNGVOI BA HiNH. , Sci ch~tng tjltffg 5 . ' Duver. g SCT IBS

So dang ky IlllU him;;'W~~: 1 7' fA- Jf%ii. BYT -TB-CT (Registered number) .

. I~N Q. 4-'~

~~---&, #.,.. ,..... ~

::{ ,': '.:' ~ \~ PH6 OHU TIOH , .:;0.5/ j 'I . . . Yj~Yf / ~ t<ink (lJiin.. dt5iell .' . ~ ~ ... ~:~~~ -~ If/

\ BAN SAO \

CHUNGNHAN •

CONG TY TNHH SAN XUAT vA THUONG MAl " '" THIET BI Y TE HOANG SON •

ABN: 0105964587

Xii Lien B\lt, Huy~n U ng Hoa, Thilnh Ph6 Hil Nl}i, Vi~t Nam

H¥ THONG QUAN LY CHAT LU<}NG

theo cac yen cAu ctia tieu chuAn:

ISO 13485:2003

Dang kY chfrng nb~n bao gAm )jnh v .... c: San xu§t vii kinh doanh thi~t bj Y t~.

Ngily chung nh~n g6c: 12/0112016 Ngay cAp pbCp/cAp Il,Ii: 12/0112016

Craig J Bates

•

Quatest 1 ~ • J , z

TONG CVC TlEU CHUAN 1)0 LUONG CHAT LU<;lNG Directorate for Standards Metrology and Quality

TRUNG TAM KY THUAT TIEU CHUAN 1)0 LUONG CHAT LU<;lNG 1 Quality Assurance and Testing Center 1

KET QUA THO' NGHIEM •

TEST RESULT

I ,Ten rn ft u thll lSalliple nallie Day hut nhot

Dio chi! Address: 8 Hoang Quac Vi~t

COu Giay, Ha Nili, Vi$t Nom

Di$n thOQi{Tel: (84-4) 38361399

fax: (84-4) 38361199

Trang/pagc:,,::I/-d.

2, KI1!\ch hang lelistOllier COllg ty TNHH san xuAt va thu'o'lIg m!,li y t~ Hoang SO'II

3,s6 IlI<;mg rn ft u I Quantity 10 cai 4,Ngay nh~n mft u: 20 1 :' 201 5 Date a/ receiving:

5,Tinh tr~ng milu I Status o/salliple G6i PE kin

6, Tha i gian tl1\lc hi~n 1 Test duration Ttl ngayl FrOIll : 24 / 3 1 201 5 d8n ngayl to: 04 / 4 1201 5

STT Tell chi tie ll PIIIl'{mg pluip t/II;' KBt qllri /telll SpecificatiollS Test method Results

I. D(\ va khu§n Duqc di~n Vi~ t Nam III : 2002 D!,II lieu chufin

HQ N9i ngay 06 / 4 1201 5

GIAM DOC/ DIRECTOR P TRU'ONG PHONG THU NGHIJ):M

VI SINH

LC Thj Thuy H~ng

I . PhiJII kit qlla lilly chi co gia Irj dili lifi milll tIll ; do khach heing (11m lai. This lesll'eslllts is mIlle ollly/or samples laken /)1' clls/omer.

2. Khol1g (11((1C trich sao 11191 phJ" kJ, qua mil ~Idl/ khoflg (lm!c Sil tl611g i ' cl;a 'rt lllg ,dill K)I IIIII(il I. This lest resulrs sltall Jlor reproduced excepr iI/full, I\ 'irltour 'lte lI'eiuell approl'ed of QUAT EST I.

3, Tell mJII wi lell kluklt helng du(,Yc glti tlt eo yell c6 11 clio kluiclt Itelng, ' Name a/sample alld cllstomer are I\'riffell as clIstomer S reqllest,

TNI!lM /05,J- L sdOO,20 14

Quatest 1 TONG CVC liEU CHUAN DO LUONG CHAT LUQNG Directorate for Standards Metrology and Quality

TRUNG TAM KY THU,b.T liEU CHUAN DO LUONG CHAT LUQNG 1 Quality Assurance and Testing Center 1

KET QUA THO' NGHIEM •

TEST RESULT

I Ten milu thtl /Sample nGme Day cho an

D!o chi! Address: 8 Hoang Qu6c Vl$t

COu Gi6y, H6 Nill, Vi$t Nom

Ili$n thOQi/Tel: (84-4) 38361399

Fax: (84-4) 38361199

Trang/p,gc:",,-:/!:t.

2.Klulch hilllg /elistalller Cong ty TNHH san xuilt va t1IU'O'ng m\l i Y t~ Hoang So'n

3,s6 IW;l'I1g milu / Quantity 10 cai 4,Ngay Ilh ~n milu: 20 1 31 20 15 Date ofreceivillg :

5,Tinh tr~ng milu / Statlls of sample Goi PE kin

6, Tha i gian Ih\IC hi ~n 1 Test duration Ttl ngayl From: 24/3 120 15 d~n ngayl to: 04 / 4 12015

STT Tell clti tilitl PllIl'{fIIg pluip tlt ir Ket quit !telll Speci(icat iOlls Testlllethod Results

I. £)9 vo khuAn D1IQ'C di~n Vi~t Nam III : 2002 £)~t lieu l nuAn

Hit N(ji ngity 06 1 4 12015

GIA.M DOC! DIRECTOR 1', TRUONG PHONG THU NGHIJ):M

VI SINH

LC Thj T huy H~ng

I. PJU"&II kci, qlla lI(iy chi co gid Irj (16i l'(yi nulll tlllf do klIne/t //{illg (1/((1 {(Yi. 71,is fest resu/Is is mille ollly fol' samples takell /Jv customer.

2. Khollg (lir(Jc trfch sao lIujt 1)/l(i/1 kci, ql/rlllay ~,cfll khong rttr(Jc S(f (tbug .,/ clio (rung I(im K)i fllf{{)1 I. This fest resllits s"aff 110' reprodl/ced excep, ill luff, wi,holl' 'he wei"ell approred of QUATEST J.

3. Ten 111611 Wllell k/ulcli /uing {"r(le ghi Illeo yell cdll ctia k/uicli /uing. Name o/salllple a"d cllstolller af'(' It'rillell as clls'omer:~ request.

TNIllM/OS.3-LsdOO.20 14

Quatest 1 TONG CVC TlEU CHUAN DO WONG CHAT WONG Directorate for Standards Metro logy and Quality

- - -- -~ ~ ~ TRUNG TAM KY THU~T TIEU CHUAN DO WONG CHAT WONG 1

Qua lity Assurance and Testing Center 1

S6/No: tl.Q)11 ... 8.~/rrrY/O} ...

KET QUA THO' NGHII;M TEST RESULT

I.Ten mii" thir /Sample nallle Day tho' oxy

qa chI! Address: 8 Hoang QuOc Viet

Cou Giay, He N¢i, Vi~t Nom

Di$n th09l/Tel: (84-4) 38361399

Fax: (84-4) 38361199

Tran g/l'agc: ... -:ild ..

2.Klll\ch hang /euslOmer Cong ty TNHH san xuilt va t/lU'o'ng ml,li y t~ Hoang SO'I1

3,s6 Ilf(1ng mft" / Quanlity 10 ca i 4.Ngay nh~n mii,,: 20 1 31 201 5 Dale o/receiving :

5 .Tinh tr~ng milu / Sialus 0/ sample Goi PE kin

6. Tha i gian tl1\fC hi~n 1 Tesl duralion Tir ngayl From: 24 / 3 120 15 cl~n ngayl 10: 04 14 1201 5

STT Tell chi lieu PIIII'{fIIg "llIip tilli' Kb ql/{i Ilem Specifications Test mel hod Results

1- ])9 vo khu§n DUqc di6n Vi~t Nam III : 2002 EJ~t tieu chu§n

Hit N(Ji ngay 06 1 4 12015

GIAM DOC! DIRECTOR P TRUONG PHONG THU NGHlJ):M

VI SINH

LC Thi Thuy Hhg

I. Phi§u kit qlla l1(iy chi co gia 11'; ddt' val nu711 1111( do kl/{ich /uillg alfa to'i. This lest results is mIlle ollly/or sall/ples takell by customer.

2. KIIOl1g alf(1c trlch sao III?>! ph611 kat ql/ci nriy nau kllong rlu(lc S{f d6ug Ji Clio (rllllg trim K)i '/lU(a I. This rest results shallllot reprodl/ced except illfllll, without/he weillell apprm'ed ofQUAT£ST I.

J, Tt!1I "uill I'(llell kh(ich hallg (ll({),c ghi theo yelf c611 clia klutch /uillg. . Name of sample and ClIstOIllel' (Ire lI'rilleli as clIstomer S request,

TN I3M/05.3-LsdOO.2014

Quatest 1 ~ A J • ~

TONG CUC TIEU CHUAN DO WONG CHAT WONG Directorate for Standords Metrology and Qu'ality

TRUNG TAM KY THU,4.T TIEU CHUAN DO WONG CHAT WQNG 1 Quality Assurance and Testing Center 1

KET QUA THO' NGHIEM •

TEST RESULT

I.Ten m§u thir /Samp/e name Day hUt dich phh thu~t

Dio chi! Address: 8 Hoang Qu6c Vi~t

Cou Gi6y. He N¢i. Vi$t Nom

Di~n th09i/Tel: (84-4) 38361399

Fax: (84-4) 38361199

Tranglragc: ... 1.(-1. ...

2. Khaeh hilllg /eus/omer Cong ty TNHH san xuilt va thu'o'ng m~i y t~ Hoang SO'n

3.s6 IlrQ'ng m§u / Quan/ity 06 cili 4.Ngay nh~n mall: 20 / 3/ 201 5 Da/e of receiving:

5.T;nh Ir~ng mau / Status of sample Go; PE kin

6. Thai gian th\re hien / res/ dura/ion Tlr ngay/ From: 24 / 3 / 20 15 d~n ngay/ /0: 04 / 4 / 20 15

srT Tell clti lii! 1I PllIl'{mg pluip lit Ii' K€I qllii Item Specifications res/me/hod Resul/s

I. DO vo khufrn Dll9'C dien Vi~t Nam 1lI : 2002 D(lt tieu chufrn

Hit N9i ngity 06 1 4 12015

P. TRUONG PHONG THU NGHIJ!:M VI SINH

Le Thi Thuy Hiing

1. Phidu kdt qua 11(;)' eM co girl Irj (fbi n5-i mall II,,; do kh(iclt hang dlra (ai. This lest res"'fs is mIlle Dill" {or samples raken bv C/lstomer,

2. KluJlIg (hr(fc Irich sao mdl plul/1 kdl quci /lay ~/(jl/ khollg rll/'(fc S{f dAng .\) e/fa Irung trim Kji tllll(ft I . Tltis les! resulls shalf 110/ reproduced except ill/II11, withoWlhe weiltell apPI'o\'ed o{QUATEST I.

3, Tell /Juiu WI tell klulch luillg (/1f(1C glti tlleo yell (,'{1 1/ Cl;a kluich hang, Nome a/somple all(/ customer are 1\'1';11('1/ as customer S request.

T NII3 M /05.3 - L sdOO.20 14

Quatest 1 TONG CVC TIEU CHUAN DO LUONG CHAT LUONG Directorate for Standards Metrology and Quality -~ - - -~ ~ ~

TRUNG TAM KY THU~T TIEU CHUAN DO LUONG CHAT LUONG 1

Dio chi! Address: 8 Hoang Qu6c Vi~f Cou Gi6y, He NQi, Vi$t Nom

Di$n th09i/Tel : (84-4) 38361399 Quality Assurance and Testing Center 1 Fox: (84-4) 38361199

Trang/Page: .. .I!/...

KET QUA THlJ' NGHIEM •

TEST RESULT

I.Ten mii ll thlr ISalllple nallle Oily thong h~u mon

2.Kluleh hang le ustolller Cong ty TNHH san xu fit vii thu'O'ng m\li Y t~ Hoang SO'n

3.S6 Im;rng mllll I Quantity 10 cai 4,Ngay nh~n miill ." 20 1 31 201 5 Date o/receiving ."

5,Tinh tr~ng miill I Status o/salllple G6i PE kin

6. Tha i gian th\re hi ~n 1 Test duration Tir ngayl Frolll: 24 / 3 120 15 d~n ngayl to: 04 / 4 1201 5

STT Tell chi lieu PllIl'llllg pluip t/iri' Kh qui! Itelll Specifications Test lIIethod ResUl is

J. D9 vo khllAn DlI9'c diSn Vi~t Nam III : 2002 D(\t tieu chliAn

Hit N(J i ngay 06 1 4 /201 5

GIAM noci DIRECTOR P TRU'ONG PHONG THU NGHIJ):M

VI SINH

Le Tit! Tltuy H~ng

I . P/Ili ll kd, quci uriy clt i c6 giri '''; ct6i l'oi mrlu 1/11;' do khacll hrillg rtlfa foi. This fest results is mIlle ollh' {or sall/ples raken b\' e llS/Oilier.

2. Khollg t/U(1C (rich sao 11191 p116" kat qua lid)' ~ldll khong alr(Jc s(r (1611g ,\1 C1ialrtll1g trim Kji Ihu(i/ I. This /estreslIlts shallllof reprod//ced except ill {ull. witholll the weitlell ap/Jro\'ed o{QUATEST 1.

3. Tell mciu \'(1 tell khach hang dU(Jc ghi theo ,;'eu C(;u efta kh(lch /uillg . Name o{ sample alld clls/omer are \\'ritrell as cllstomer :\. reqllest.

--

I

TNIllM/OS.3- LsdOO. 20 14

A' .. "" , .( TONG CUC TlEU CHUAN £)0 LUONG CHAT LUONG Directorate for Stondards Metrology and Qu'ality Quatest 1 .. ~ .... _, , .t

TRUNG TAM KY THUAT TlEU CHUAN DO LUONG CHAT LUONG 1 Quality Assurance and Testing Center 1 .

D!o chi! Address: 8 Hoang Quae Vi$t

Cau Glay. He N¢i. Vj$t Nom

DI$n thOQi/Tel: (84-4) 38361399

Fax: (84-4) 38361199

S6/No :.d£J.ri\l .. 9.1 lt ./lJ'lH ./.!.) .. Tranglp'gc: ...... 1/1 .. .

KET QUA THO' NGHIEM •

TEST RESULT

I . Ten milu Ihlrl Name of sample: Day hut nh6t 2. Khach hang/ Customer: C6ng Iy TNHH san xual va Thllong m~i Thiel bj y Ie Hoang Son 3. S6 IlI<;mg milul Quallliry: 04 cai 4. Ngay nh~n milul DOle of receiving: 20103 I 2015 5. linh Ir~ng maul Slalus of sample: MAu nguyen san pham 6. Thai gian Ihlr nghi¢mlTesl duralion: Tlr ngayl From: 20103/20 15 den ngaylTo: 081 04 l iS

s rT Tell chi lieu I'/u{(mg phap IIllt Muc gi6i han Keiqud Ilem Speci{icOliolls Tesl melhods QCVN 12- 1:I I/BYT ReslIlls

I. T6ng kim lo~i n~ng qui ra Pb QCVN 12- 1:2011/BYT" ) :> 1,0 < 1,0 (Dietl ki¢/l ,IlI( /lglri¢m: 61J'C , 30plHil,rollg

axil axe/Ie 4%) I'glml 2. Ham IU<;1ng c~n kh6: Dieu ki¢n ngfim : QCVN 12- 1 :2011/BYT")

1.61J'C, 30plllil , Irollg w ac, J.lg/ml .. :> 30 < 1,0 2. 6(J'C I 30 pluJ(, 11'0118 axitacetic4% J.lg/ml " :> 30 < 1,0

3. Ham 11I<;1ng kim lo~ i IMi nhiem: QCVN 12- 1:2011 /BYT" ) Ham 11I<;1ng Pb J.lg/ml " :> I,D Kh6ng pl"'1 hien

(LOD= O,O!)

Ham 11I<;1ng Cd J.lg/ml " :> 1,0 Kh6ng plul t hi¢n (LOD= om)

-(*) QCYN12- 1. 1 I /BYT- Quy chuan Ky th u~t Qu6c gla v~ an lOan v~ smh d61 vetl bao bl, dyng clJ bang nln,1a t6ng hqp 1U~:p xuc (n.re (ICp VOl Ih'!c pIH~m .

PHU TRAcH PHONG THO NGHIEM ., A '

HOA-THl)'C PHAM

I.

2.

3.

Do Van Thich PH6GIAM D6c

fjlfn? fitufu ~

Phidll kdl qlla nay chi co gia II'; dbi "iti /I/{lu 1111; do kl/{ich I/{Ing duo liti. This rest reslllts is value Oll~)! Jor sall/ples taken b)! cllstomer. Khollg ctu(jc Irich sao mOl pl/{1n kdl qlla lilly ~/(fll khong {tU(!C Sil (16Ilg)i clia frlmg I(im K)i 1111101 I . This res! reslIlts shalll/ot reproduced except il/Jull, H:it"olll tlie weiftell approved oJQUATEST I. Tell mall wi len khach I/{illg ilu(fc ghi theo yell call clia kluich IUIIIg. Name of sample al/d customer are II'ri rrell as CIIS/Olller S reques,.

2015

T N/I3 M105.3-LsdOO.20 14

Quatest 1 TONG CVC TI EU CHUAN DO LUONG CHAT lUONG Directorate for Standards Metrology and Quality

TRUNG TAM KY THU,b.T TlEU CHUAN DO lUONG CHAT lUONG 1 Quality Assurance and Testing Center 1

KET QUA THO' NGHII;M TEST RESULT

I. Ten milll thlr/ Nallle of sallIple: DflY cho an

Ofo chil Address: 8 Hoang Qu6c Vi$1

Cou Giay. He N¢ i. Vi$1 Nom

Oi$n IhOQi/Tel: (84-4) 38361399

Fax: (84-4) 38361199

Trang/Pagc: ..... .d/1. ..

2. Khach hlmg/ Customer: C6ng ty TNHH SX va TM Thiet bi y te Hoang Son 3. SO Ilfgng milli/ QuamilY: 02 mil ll 4. Ngay nh~ n milli/ Dare of receivillg: 02/03/2015 5. l1nh tr~ng maul SlaWS ofsalllple: Milu nguyen san ph am 6. Thai gian thiI nghi¢m/ Tesl durmioll : Ttl ngay/ Frolll : 02/03 /2015 den ngay/To: 16/03/15

STT Tell chi lieu P/lI{(fIIg p/ll!P IIlIt M(rc gioi h~n Kei qud Item Spec/jicmiolls Tesl mel/wds QCVN t2- t:II/IlYT Resulls

1. T6ng kim l o~ i n~ng qui fa Pb QCVN 12- 1 :20 l llBn'" $ 1,0 < 1,0 (Dllu kif/l (fur IIghiflll : 6CPC, 30p/lflt 1I"0llg

axil (fxe fic 4%) flg/1II1 2. Ham ILCqng c~n khO: Diell ki (\n ngiim : QCVN 12- 1 :2011IBYl'"

1.6(J'C, 30 p illil. rrollg II/{ae, f.lg/ml .. $ 30 < 1,0 2. 6(f'C, 30 /lilll" (I"Ollg axitacetic4% ~lg/ml .. $ 30 7,0

3. Ham Il!qng kim l o~ i thOi nhi;\m: QCVN J2- 1:201IIBYl'" I-Utln Itrqng Pb ~lg/ml " $ 1,0 KhOng ph,;t hi¢n

(WD ; 0._' )

Ham luqng Cd J.lg/ml " $ 1,0 Khong pluit hi¢n (WD ; 0.1)

.- - .. , . " (*) QCVN 12-1: I I / BY 1- Quy chu[tn Ky I hu~t QU6c gw v~ an loan \'~ sinh dOl Val bao b l, dl,mg Cl,l bang nhva 16ng hqp Iler XtiC trvc tlCp Val (llliC pham.

Hii N¢i , lIgay 16 1ir6l1g 03 111illl 2015

PHl) TRAcH PHONG THUNGHI~M HOA-THVC PHAM

Do Van Thich

I . Pllidll kdt qll(i miy chi co giit tri (16i I'ifi nl(ill 1111; do kltaclt Itimg (1/{a ta i. This tesl results is vallie 01l ~)1 for samples taken by clislOmel:

2. Khollg d /{(fc tr ich sao 1119t pll(ill kdt qlld I1(IY I/du khollg d /{(1c SI.r (16Ilg)' ella tn lflg f(i lll Ky tllll(1I I. This test resliits shall 1101 reproduced except illfll/l, lI'ill/olIl the lI'eillell aplJrOl'ed o{QUAT£ST I.

3, Tell mall 1'(1 tell kJl(lch /I(lllg dl((lC glli thea yell Crill clla kJl(ich Iulilg. . Name of sample and clistomer (Ire written as customer s request.

TNII3M/OS.3- LsdOO.20 14

_, _ _, ~ .c

Quatest 1 TONG CVC TIEU CHUAN DO LUONG CHAT LUQNG Directorate for Standards Metrology and Quality

TRUNG TAM KY TH U,i.T TlEU CHUAN DO LUONG CHAT LUQNG 1 Quality Assurance and Testing Center 1

D!a chi! Address: 8 Hoang Qu6c Vi$t

COu Gi6y, Ha N¢i, Vi$t Nom

Di$n thOQiiTel: (84-4) 38361399

Fox: (84-4) 38361199

Trang/p,gc:"" AI.i. .,

KET QUA THO' NGHIEM • TEST RESULT

I , Ten mAu thill Name of sample: Day tha oxy 2, Khllch hangl Customer: COng ty 1NHH san xuilt va Thuang mai Thiet bi y te Hoang San 3, S6 Iw;mg mAul Quaillity: 04 clii 4, Ngay nh~n m Aul Dale of receiving: 201 03 I 2015 5, Tlnh tf~ng milul Status of sample: MAu nguyen san phdm 6, 11'0i gian thll nghi¢mlTest duration: Tit ngayl From : 20103/2015 den ng'ayl To: 08/04 l i S

STT Tell chi liell P/1I{(fIIg plulp IIlIt M(lc gi6i h~n Kt!i ,!Iui Item Specifications Test methods QCVN 12-1:ll/BYT Results

L T6ng kim lo~i n~ng qui fa Pb QCVN 12-1 :2011/BY1" ) '" I ,D < I,D (Dieu kir!Jll lllfllghi¢m: 6frC. 30phu[ (rong

axil axetic 4%) Ilg/m{ 2, Ham IU<Jng c~n khO: Dieu ki¢n ngdm : QCVN 12- 1 :20 II/BY1" )

1, 60'C , 30pluil, Irollg ""oe, Ilg/ml .. '" 30 < I,D 2.6Cf'C, 30 pJl/if, II"Ollg axiracelic4% Ilg/ml .. '" 30 < I,D

3, Ham Ilf<Jng kim l o~ i thOi nhiem: QCVN 12- 1:20 11/BYT" )

Ham Ilf<Jng Pb Ilg/ml " '" I,D KhOng phat 11i ~n (LOD~ O,GJ)

Ham Ilf<Jng Cd Ilg/ml " '" I,D KhOng phat hi¢n (LOD~ 0,01)

• - .- .. ( ) QCVN I2- 1 l l /BYT- Quy chulln Ky Ih u~1 Quoc g hl v~ an to~m v¢ smh d61 VOl belO bl. d\lng ct.l bang nh~rd tOng hqp tlCp xuc lIVe IH~P Val Ihl.rc pham.

PHl) TRAcR PHONG THUNGHI~M HOA-THljC PHAM

Do Van Thich

J. phiiu kdt quri IIdy chi co giftlri (t6i I'(yi malllhlf do kll(lcll//{illg duo tai.

2015

PH6GIAMD6c

9JJifnf fiudtn ~

This test results is va/ue Oll/)'/O/" samples takell bl' customer. 2. KI/lJllg dl((lc lricll S(lO m6t ph(1II kdt quri llei), ;,dll kll6ng t"'(le S{f t/ollg)i clIa tnl11g f(im K.ii lll/f(il I.

This test results shall 1I0t reproduced except ;II/Ilf1, lI'ilholl( the lI"eillell approl'ed o!QUATEST I. 3. Tell 111(711 I'({ tell klu/c" "eing (11((lC glli Iheo yell c611 Clia kl/{klilieillg.

Name o/sample and ('uS/omer o/"e written as ('liS/Oilier S request.

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Quatest 1 TONG Cl,IC TlEU CHUAN DO LUONG CHAT LUQNG Directorate for Standards Metrology and Quality

TRUNG TAM KY THU.o.T TlEU CHUAN DO LUONG CHAT LUQNG 1 Quality Assurance and Testing Center 1

Dia chi! Address: 8 Hoang Qu6c Vi$t

COu Gi6y, Ha Nqi, Vi$t Nom

Di$n tho<,ll(Tel: (84-4) 38361399

Fox: (84-4) 38361199

S6/NO : ~4Q" 0,1::, ~ " .I ,~J",l:J "",, TranglPagc:"" 4 ,{.t",,

KET QUA THO' NGHIEM •

TEST RESULT

L Ten mau th1r/ Name of salllple: Day hut d!ch plu'lu thu~t 2, Khach hang/ Custolller: COng ty TNHH san xu1l't va Thllong m~i Thiet bi y te Hoang San 3, S6 Ilf(;mg maul Quantity: 04 cai 4, Ngay nh(ln maul Date of receiving: 20/03/2015 5, Tinh tr~ng maul Stallls of sample: Milu nguyen sim pham 6, Thai gian th l! nghi¢m/ Test duration: Tit ngay/ From: 20/03/2015 dOn ngay/ To: 08/ 04 /1 5

STT Tell chi liell Plll{(1I1g phap till; Muc giOi h~n Kei qud Ilem Specifications Teslmelhods QCVN t2-t:11!13YT Resulls

L T6ng kim lo~ i n~ng qui ra Pb QCVN 12-1 :20 II /BYT" ) " 1,0 < 1,0 (Die'u ki¢1I [Ilif IIg/ii¢I1I '- 6(fC, 30p/ult trollg

axil axe lie 4%) Jiglllll 2, Ham ltrgng c~n khO: Dieu ki¢n ngfim : QCVN 12-1:2011/BYT" )

1,6!J'C , 30 pillil, Irollg IlIrac, Jlg/ml " " 30 < 1,0 2, 6!J'C, 30 pillil, lrang ((xiracelic4% Jlg/ml " " 30 < 1,0

3, Hilm ltrgng kim lo~i thOi nhiem: QCVN 12-1:2011/BYT" ) Ham lllgng Pb Jlg/ml " " 1,0 Kh6ng p1lli1 hi¢n

(LOD= 0,01 )

Ham IlIgng Cd Jlg/ml " " 1,0 KhOng phat hien (LOD= 0,01 )

• - ; '" ' " ( ) QCVN 12-1. I I/BYT- Quy chuan Ky thu~t Qu6c g l a \'6 an toan v¢ SlIlh d61 val b<\o hi, dl;) llg Ct,! bang n h ~r'l tOng hqp lI ep XlIC Irvc tlep v 6 1 Iht.rc pMim.

PHl,! T RAcH PHONG THUNGHI1);M HOA-THT,J'C PHAM

Do Van Thich

I. Phi~" k~1 quti l1(iy chi co gici II'; {toi WIi /lui" 111l( do k/ulch luillg {t ,ra I&i.

PHOGIAM06c

Cj~"illfl !Juan ~

This leSf results is wi/ue ollly fa!' samples fakell b)1 cuslOmer ,

2. Kftollg {lu(1c lricft sao 11191 phdll kdl quti nay ~f(ju khollg dU(1C 51.' (t6I1g}' clla IJ'I/l/g I(illl KJ' IIIlI(il I. This te.\! resllils shafillot reproduced except ill/lIl1, ":itI/oUf the lI'eiltell appro\'ed o/QUAT/:;ST I .

3. Tell miiu wi (ell k/uich /uillg dlr(1c glli tileD yell c(i ll clio k/ulcll /uiug, Name of sample alld customer are lI'riffell as C/istolller:\, request,

2015

TNII3MIOS.3-LsdOO.20 14

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TONG CVC TIEU CHUAN DO Ll/ONG CHAT WQNG Directorate for Standards Metrology and Quality Quatest 1 TRUNG TAM KY THU,4,T Tleu CHUAN DO WONG CHAT WQNG 1

Quality Assurance and Testing Center 1

Dio chi! Address: 8 Hoang Qu6c Vit;lt

cau Gi6y, He N¢i, Vi$t Nom

Di$n tho<;lifTel: (84-4) 38361399

Fox: (84-4) 38361199

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KET QUA THO' NGHIEM •

TEST RESULT

l. Ten mAu lhlrl Name oj sample: Day thong h~u mon 2. Khach hang/ Customer: Cong ly TNHH san XU' 1 va Thlrang m~i TIliel bi y Ie Hoang San 3. S6 luqng miiul Qualllity: 04 cai 4. Ngay nh~n mAul Date oJ receiving: 20103/2015 5. TInh tr?ng milul SWillS oj sample: MAu nguyen san pham 6. TI,oi g ian lhlr nghieml Test duration: Ttr ngayl From: 20103/201 5 den ngayl To: 08/04 / 15

STT Tell chi lieu Phu(fIlg plu,p tllIf Muc gi6i h~n lW qlld Item Specifications Test methods QCYN 12- 1:II/BYT Reslllts

l. T6ng kim lo~i n~ng qui ra Pb QCYN 12- 1 :20 11/BYT" ) ,; 1,0 < 1.0 (Die'll ki¢" till; IIghi¢m: 6rrC. 30plltt! (rong

axil axetic 4%) J.1glml 2. Ham luqng can kh6: Dieu ki¢n ngam : QCYN 12- 1 :2011/BYT" )

J. 6(f'C, 30 pl";t, trang wac, Ilg/ml " ,; 30 < 1,0

2.6(TC, 30 pIli/I, trollg axilacelic4% Ilg/ml " ,; 30 < 1,0 3. Ham iuqng kim lo~ i th6i nhiem: QCYN 12- 1:2011 /BYT" )

Ham Itrqng Pb Ilg/ml " ,; i ,0 Kh6ng plU]1 hi¢n (LOD~ om)

Ham Itrqng Cd flg/ml " ,; 1,0 Kh6ng phal hi!,n (LOD~ o/! ' )

- - '.' .. , ("' ) QCVN 12· ) : I I/BYT- Quy chuan Ky thUi.H QuOc g la v~ an lOan v¢ slIlh d6J va. bao bl, dl,lIlg Cl,l b:1ng nlum tOng hQ'p tlCP xue true tl CP Val th~[(.: pharn.

PHt) TRACH PHONG THU'NGHI1);M HOA-THVC PHAM

Db Van Thich PH6 GIAM D6c

{j/jlfn? ffadn ~

I. p/lliu kif quri l1(iy chi co giri Ir; (tdi I'(yi mdu tlllr do khach hring (tua fai. This test resulls is mille ollly jar samples lakell bl' customer.

2. Khollg (tu(1C Irich sao m(Jt p!U;1I kril qua /leiy ~, ill khong (tu(1C s~r (tfJIIg J' clia f/"llllg lall1 Kji tllll(il I. This test results sliallnol reproduced C!xcept iI/filII. Il'itllollt rhe lI'eilfell approred o/QUATEST I.

3. Ten mdll wi thl kh(kh hllllg aU(1c ghi thea yell cr; /I c lia khach /UIIIg. Name of sample alld cllsromer are written as cusromer S requesl.

2015

TN/IlM/OS.3-LsdOO.20 14