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F:日 EAL YEAR 2□ 2ヨ

E E RTIFIEATE□ F REEISTRATI□ N
THIS CERTEF=ES
￨_
THAT:
‐
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. ‐

DANAMECOIMEDECALJOINT STOCK CORPORAT=ON ■

OFnce l No 12′ Trinh Cong Son Street′ Hca Cuong Nam′ Hai Chau District′ Da Na19‐ City′ 550000′ VIETNAM.

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■STABLISHIMIENT:
Faci‖ ty Name :Qじ ANG NAM MEDICAL DEVICES FACTORY BRANCH OF DANAMECO MEDICAL]OINT STOCK
Address :Trang Nhat 2 1ndustraI Zonef E)ien Hoa iiommune, Dien Ban Town, Quang l{am Provime, 51415,
Registration Number :3016970619
DUNS Number :555297766

OWNERノ OPERATOR:
Company :DANAMIECO MEDICAL JOINT STOCK CORPORAT10N
Address :No 12r Trinh Cong Son Street′ Hoa Cuong Nam′ HaI Chau District,Dla Nang City′ 550000′ VIETNAM
Owner/Operator Number :10071934

DETAILS IN THE ATTACHED AppENDIX A

TPS will confirm that such registration remains effective upon request and presentation ofthis certificate until the end ofthe
calendar year stated aboye, unless said registration is terminated after issuance of this cerEifcate. TPS makes no other
representation or warranties, nor does this certifcate makes any representations or warranues to any person or entity other
than the named cerLiflcate holder, for whose sole benefit it is issued. This certificate does not denote endorsement or
approval of the certiflcate-holder's device of establishment by the U.S. Food and Drug Adminitratiorl TPS assumes no liability
to any person or entity in connection with the foregoing.

Pursuantto 21 807, ?egistration of a device establishment of assignment of a registration does not in any way
denote approval the establishment or resentation that creates an of official approval
because of or possesslon ing and constitutes misb ・Ithe lJ.S.Food and
DrugAdmi does not issue the The and Drug nitration recognize
a ceftiflcate of 1lPS is

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F旧 日要E:⑫ 塑晏IR 2口 2コ
APFENDEX A‐ DETA:L5PRI口 IDuET IDEVIEE LlETINE5
Reglstration Number:3016970619 0wnerノ Operator Nuimberi■ 0071934

■
510(Ю
D465193‐ DⅨ Care
Mask, surgical E卜
01"70
2. D469242 =■￨“
KME Beddinq′ [)isposable,Medical D-Care
3. D442220 Y Gauzelsponge, internal, x-ray detectable FCare
●￨ ■■
Face Mask Per EnfOrcernent Po‖ cy For Face
4, D396711 QKR. Masks And Respirators Du‖ ng The Deciared DCare; Tamm17・ Care
■
■ Public Health Emergency
￨

5. D396709 MSH Respirator" surgical D-Care; Tammy Face Care

6. D396713 LYU Accessory, surqical aDparel DCare; Tammy Face Care
7, D398759 FX0 Suit, surqical D-Care; Tammy Face Care
8. D398761 OEA Non-surg;cal isolation gowns D-Care; Tammy Face Care 510(Ю
9. D405039 KHA Mask, scavenginq D-Care Exem膵
10. D405040 FXP Cover, shoe, operating-room D-Care
11 D405041 Bヽ VP Shoe and shoe coraer, conductive D-Care
12. D405043 Ⅸ W Shoes, operatinq-loom D― Care
13. D420695 K)〈 F Applicator, absorbent tipped, non-sterile Danameco Absorbent Tipped Applicator
14. D420696 FRL Fiber, medical, absorbent Danameco Medical Absorbent Fiber
Danameco Nonresorbable
15 D420697 NAB Gauze/sponge,nonresorbable for external use
Gauze/Sponqe For Edemal Use
Danameco Non-Woven Surgical Caps;
16. D420698 FYF Cap, surgical
Danameco Surqical Cap (Head Cover)
17. D448119 HMW DraDe, Microscooe, Ophthal mic D-Care
18. D448117 EYY Drape, Uroloqical, Disposable D― Care

19` D448118 HMT Drape, Patient, Ophthalmic DCare

F00t Wrap br Treating Restles Leg
20, D448122 OTX Care
SyndЮ me Sympゎ ms E)―

21. D448123 FQM Banclaqe, Elastic D‐ Care

22. D448120 PUI Drape, Surgical, Exempt D―Care
23. D448121 KGT Drapef AdheSive,Aerosol D-Care
24. D448115 GEC Brush. Scrub, Operatinq-Room FCare
25. D448126 EFN Cotton′ Ro‖ D― Care 510(り
Drape′ Pure Latex Sh(Ю t′ Wi廿 l Sel■ Rdaining exempt
26. D448116 EYX D-Care
輌nger Cot

27 D448127 Cushion, Pad, Denture, Wax Impregnated

NKJ D-Care
Cotton, Over The Counter
28. D448113 ‐ FYE Dress, Surgical D-Care ■‐
lt
29. D4124 KGX Tape And Bandaqe, Adhesive D-Care R

30, D4481lZ FME Gown, Examination D-Care

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31 D448125 MHVV D劃 nヴ 面 藤 覇
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薇罐ジ≦予て籠 こ こ
D‐ Care 亀
32. D448627 ERY Draロ イ〔 超ヘ― D-Care
33. D448628 NEC 艶 イ i瀬遇 が 締 ド ヽ 2raで 1二
対 ン/

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