HomeChinaAnrei Medical (HangZhou) CO., LTD.

Anrei Medical (HangZhou) CO., LTD.

China · Hangzhou Zhejiang
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Israel, Russia — 4 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
12listed device types
Class I 3Class II 9Class III 0
plus 12 registration records and 6 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
2registered devices
Class I 2
3 including historic records
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
2registrations
RURussiaRoszdravnadzor
1active registrations
Class 2a 1
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, 6 510(k), 0 PMA
Brazil2 confirmed, 1 excluded
Manufacturer names merged into this page: Anrei Medical (HangZhou) CO., LTD. · ANREI MEDICAL (HANGZHOU) CO., LTD.

Company information

Country
China
City
Hangzhou Zhejiang

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

22020 · K201771
32021 · K210917
12022 · K212999

FDA listed device types

showing 8 of 12
Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection 1Bronchoscope (Flexible Or Rigid) 1Endoscopic Injection Needle, Gastroenterology-Urology 1Endoscopic Guidewire, Gastroenterology-Urology 1Endoscopic Grasping/Cutting Instrument, Non-Powered 1Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt 1Unit, Electrosurgical, Endoscopic (With Or Without Accessories) 1Hemostatic Metal Clip For The Gi Tract 1

Registration details (sample)

MarketIdentifierNameClass / date
USK212999Multi-Functional Electrosurgical Knife2022-03-21
USK210917Single Use Injection Needle2021-05-28
USK202987Rescue Pulmonary Grasping Forceps2021-04-29
BR81040530091BOCAL PARA ENDOSCOPIAClass I
BR81169960004Pinça de Biopsia Reutilizável BioflexClass I

Similar companies

Acoresmed Co., Ltd.
China · markets 1
Aimagine Care Technology Co., Ltd.
China · markets 2
Allmed Medical Products Co. Ltd.
China · markets 12
ALTON(shanghai)medical Instruments Co.,Ltd
China · markets 12
Ambulanc (Shenzhen) Tech. Co. Ltd.
China · markets 10
Andon Health Co., Ltd.
China · markets 10
Is this your company? Claim the page, add information or report a data error.Claim / report an error →