HomeChinaBEIJING DEMAX MEDICAL TECHNOLOGY CO., LTD.

BEIJING DEMAX MEDICAL TECHNOLOGY CO., LTD.

China · Beijing
✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Taiwan, Singapore, South Korea, Australia, Israel, Russia — 8 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
5listed device types
Class I 1Class II 4Class III 0
plus 12 registration records and 4 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
36registered devices
Class I 6Class II 30
40 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
3valid device licences
Class II 3
SGSingaporeHSA SMDR
1device registrations
CLASS B 1
KRSouth KoreaMFDS GMP
2GMP quality-system certificates
Import 2
AUAustraliaTGA ARTG
20active ARTG entries
Class I 3Class III 4IIa 11Class Is (sterile) 2
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
7registrations
RURussiaRoszdravnadzor
3active registrations
Class 2a 3
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 States12 registration records, 4 510(k), 0 PMA
Brazil36 confirmed, 0 excluded
Manufacturer names merged into this page: TIANJIN DEMAX MEDICAL TECHNOLOGY CO., LTD. · BEIJING DEMAX MEDICAL TECHNOLOGY CO., LTD. · BEIJING DEMAX MEDICAL TECHNOLOGY CO.,LTD.
Same-named companies — This database also contains companies with near-identical names: TIANJIN DEMAX MEDICAL TECHNOLOGY CO., LTD.. Company name alone cannot separate their registrations, so the figures below may include either.

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

12015 · K140943
22023 · K222184
12024 · K242248

FDA listed device types

Introducer, Catheter 1Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass 1Syringe, Balloon Inflation 1Clamp, Vascular 1Board, Arm (With Cover), Non-Sterile 1

Registration details (sample)

MarketIdentifierNameClass / date
USK242248Introducer Sheath Kits2024-08-22
USK222184Introducer Sheath Kits2023-02-21
USK222182Radial Artery Compression Tourniquets2023-01-04
BR81414959015Kit de Dispositivo de intervençãoClass II
BR81414959016Kit de Dispositivo de intervenção com conector Push-click e tubo de exClass II
BR81414959017Kit de Dispositivo de intervenção com conector Push-clickClass II

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