HomeViet NamQUANG NAM MEDICAL DEVICES FACTORY BRANCH OF DANAMECO MEDICAL JOINT STOCK CORPORATION

QUANG NAM MEDICAL DEVICES FACTORY BRANCH OF DANAMECO MEDICAL JOINT STOCK CORPORATION

Viet Nam · Dien Ban Bac Ward ?A N?Ng
✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
32listed device types
Class I 24Class II 7Class III 0unclassified 1
plus 32 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States32 registration records, 1 510(k), 0 PMA
Manufacturer names merged into this page: QUANG NAM MEDICAL DEVICES FACTORY BRANCH OF DANAMECO MEDICAL JOINT STOCK CORPORATION
Same-named companies — This database also contains companies with near-identical names: Danameco Medical Joint Stock Corporation. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Viet Nam
City
Dien Ban Bac Ward ?A N?Ng

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

12022 · K213970

FDA listed device types

showing 8 of 32
Cap, Surgical 1Gauze / Sponge,Nonresorbable For External Use 1Cushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter 1Bedding, Disposable, Medical 1Drape, Adhesive, Aerosol 1Dressing, Compression 1Tape And Bandage, Adhesive 1Bandage, Liquid, Skin Protectant 1

Registration details (sample)

MarketIdentifierNameClass / date
USK213970D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply2022-01-23

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