HomeTIANCHANG DONG´ AN PROTECTIVE EQUIPMENT CO., Ltd

TIANCHANG DONG´ AN PROTECTIVE EQUIPMENT CO., Ltd

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Saudi Arabia — 3 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
1510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
12registered devices
Class I 12
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
12registered 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 States0 registration records, 1 510(k), 0 PMA, 5 excluded
Brazil12 confirmed, 9 excluded
Saudi Arabia12 confirmed, 5 excluded
Manufacturer names merged into this page: TIANCHANG KANGTEMEI PROTECTIVE PRODUCTS CO., LTD. · TIANCHANG KANGHUI PROTECTIVE PRODUCTS INDUSTRY & TRADING CO. LTD · TIANCHANG DONG´ AN PROTECTIVE EQUIPMENT CO., Ltd · Tianchang Kangtemei Protective Products Co.,Ltd · TIANCHANG KANGTEMEI PROTECTIVE PRODUCTS CO. LTD · Tianchang Kangtemei Protective Products Co., Ltd.

Company information

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

12021 · K211255

Registration details (sample)

MarketIdentifierNameClass / date
USK211255Surgical Mask2021-08-28
BR80695710044TOUCA DESCARTÁVEL NÃO ESTÉRIL BIODESCClass I
BR80695710016MÁSCARA FACIAL CIRÚRGICA TRIPLA BIODESCClass I
BR80695710017AVENTAL DESCARTÁVEL NÃO ESTÉRIL BIODESCClass I
SAME0000011078SFDAA00001Disposable Bouffant Cap
SAME0000011078SFDAA00002Help Disposable Underpad

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