HomeChinaZHUHAI DR MEDICAL INSTRUMENTS CO., LTD.

ZHUHAI DR MEDICAL INSTRUMENTS CO., LTD.

China · Zhuhai Guangdong
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Australia, Hong Kong, Israel — 5 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
4listed device types
Class I 0Class II 4Class III 0
plus 3 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
13registered devices
Class I 1Class II 12
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
4active ARTG entries
IIa 2Class Is (sterile) 2
HKHong KongMDACS
1valid listings
Class II 1
ILIsraelAMAR
2registrations
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, 2 510(k), 0 PMA, 44 excluded
Brazil13 confirmed, 27 excluded
Saudi Arabia0 confirmed, 3 excluded
Canada0 confirmed, 4 excluded
Manufacturer names merged into this page: ZHUHAI DR MEDICAL INSTRUMENTS CO., LTD. · ZHUHAI DR MEDICAL INSTRUMENTS CO.,LTD · ZHUHAI DR MEDICAL INSTRUMENTS CO. LTD.

Company information

Country
China
City
Zhuhai Guangdong

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 · K212226
12026 · K251788

FDA listed device types

Syringe, Antistick 1Injector And Syringe, Angiographic 1Needle, Hypodermic, Single Lumen 1Clamp And Cutter, Umbilical 1

Registration details (sample)

MarketIdentifierNameClass / date
USK251788Extension tube2026-03-05
USK212226DR Safety Syringe, Sterile Hypodermic needle for Single use2021-09-29
BR81565149016Kit Joint Desc. Tunel do CarpoClass II
BR10216839016EXTENSOR VALVULADOClass II
BR10289689034Cateter para punção arterial MedikaClass II

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