HomeChinaGERUI Medical Products Co., Ltd.

GERUI Medical Products Co., Ltd.

China · Changzhou Jiangsu · geruimedical.1688.com
✓ Record-verifiedregistrations found in 6 marketsEU SRN CN-MF-000010550

This company has registrations in European Union, United States, Brazil, Taiwan, Australia, Israel — 6 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
9UDI-DI device records
Class I 9
USUnited StatesFDA openFDA
9listed device types
Class I 9Class II 0Class III 0
plus 9 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
1registered devices
Class I 1
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
1valid device licences
Class I 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
9active ARTG entries
Class I 3Class Im (measuring) 6
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
4registrations
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.

European Union9 raw hits, 0 excluded, 9 confirmed
United States9 registration records, 0 510(k), 0 PMA
Brazil1 confirmed, 0 excluded
Manufacturer names merged into this page: GERUI MEDICAL PRODUCTS CO LTD · GERUI MEDICAL PRODUCTS CO.,LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000010550
EU authorised representative
RIOMAVIX SOCIEDAD LIMITADA

Company information

Country
China
City
Changzhou Jiangsu
Website
geruimedical.1688.com
Product categories
Integrated Care, Rehabilitation & HomecareConsumables, disposables & infection control

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 listed device types

showing 8 of 9
Forceps 1Endoscopic Bite Block 1Container, Liquid Medication, Graduated 1Container, Specimen, Non-Sterile 1Clamp 1Clip, Nose 1Razor, Surgical 1Curette, Ear 1

Registration details (sample)

MarketIdentifierNameClass / date
EU06974567650067Umbilical Cord Clamp ClipperClass I
EU06974567650142Class I
EU06974567650234Bite BlockClass I
EU06974567650227Medical ForcepClass I
BR10150470580Grampo Umbilical FoyomedClass I

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