HomeChinaBEIJING KREATE MEDICAL CO., LTD.

BEIJING KREATE MEDICAL CO., LTD.

China · Beijing
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Hong Kong — 2 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
pendingnot queried
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
2listed device types
Class I 0Class II 0Class III 0unclassified 2
plus 3 registration records and 3 510(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
2valid listings
Class III 2
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 States3 registration records, 3 510(k), 0 PMA
Manufacturer names merged into this page: BEIJING KREATE MEDICAL CO., LTD.

Company information

Country
China
City
Beijing

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

32026 · K261646

FDA listed device types

Dressing, Wound, Drug 1Absorbable Synthetic Wound Dressing 1

Registration details (sample)

MarketIdentifierNameClass / date
USK261646Redermax® Antibacterial Wound Matrix2026-08-14
USK260020Redermo Wound Matrix2026-04-16
USK251582Redermax Antibacterial Wound Matrix2026-02-02

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