HomeChinaBeijing iKey Medical Device Technology Co., Ltd.

Beijing iKey Medical Device Technology Co., Ltd.

China · Beijing · www.ikey-medical.com
✓ Record-verifiedregistrations found in 2 marketsEU SRN CN-MF-000008526

This company has registrations in European Union, United States — 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
18UDI-DI device records
Class IIb 18
USUnited StatesFDA openFDA
1listed device types
Class I 0Class II 1Class III 0
plus 1 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
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
pendingnot queried
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.

European Union21 raw hits, 3 excluded, 18 confirmed
United States1 registration records, 0 510(k), 0 PMA
Manufacturer names merged into this page: BEIJING IKEY MEDICAL DEVICE TECHNOLOGY CO., LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000008526
EU authorised representative
Lotus NL B.V.

Company information

Country
China
City
Beijing
Website
www.ikey-medical.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesMedical Devices & Clinical EquipmentSurgical systems & instruments

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

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer 1

Registration details (sample)

MarketIdentifierNameClass / date
EU06932172516734iKeyClass IIb
EU06932172516727iKeyClass IIb
EU06932172516710iKeyClass IIb
EU06932172512859iKeyClass IIb

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