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iRay

China · 上海 · www.iraygroup.com
✓ Record-verifiedregistrations found in 8 marketsEU SRN CN-MF-000037606Unified social credit code 91310115570750452T

This company holds 8 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Canada, Singapore, Australia, Hong Kong — 7 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
8China registrations
Class II 8
as of 2026-09-04
EUEuropean UnionEUDAMED
31UDI-DI device records
Class I 1Class IIa 30
USUnited StatesFDA openFDA
4listed device types
Class I 0Class II 4Class III 0
plus 20 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
1registered device records
Class IIa 1
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
6 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
2device registrations
CLASS B 2
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
IIa 1
HKHong KongMDACS
1valid listings
Class II 1
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 Union171 raw hits, 140 excluded, 31 confirmed
United States20 registration records, 0 510(k), 0 PMA, 7 excluded
China8 certificates (Class III 0 / II 8 / I 0), as of 2026-09-04
United Kingdom1 confirmed, 1 excluded
Brazil0 confirmed, 2 excluded
Manufacturer names merged into this page: iRay Group · IRAY GROUP

Regulatory identity

EU manufacturer SRN
CN-MF-000037606
EU authorised representative
iRay Europe GmbH
UK responsible person
W&H (UK) Ltd
Unified social credit code
91310115570750452T
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
452
Annual revenue
RMB 100–500M
Website
www.iraygroup.com
Product categories
医用影像医用成像器械

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.

Business registration

Registration status
Active
Incorporated
2011-03-07
Registered capital
CNY 211,411,684
Paid-in capital
CNY 312,096,294
Legal form
Joint-stock limited company (listed)
Industry classification
Special-purpose equipment manufacturing
Last approval date
2026-01-09
Recognitions
National High-Tech EnterpriseSRDI SMEGazelle enterpriseTechnology "Little Giant"Innovative SMEAbove-designated-size industrial enterprise
Listing
Listed on the STAR Market

Business registration data from Tianyancha, as of 2026-09-02. Public registry information only; legal representative and contact-person details are not collected. The figure is the number of employees enrolled in social insurance as declared by the company, which may differ from actual headcount.

FDA listed device types

System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations 1System, Image Processing, Radiological 1System, X-Ray, Extraoral Source, Digital 1Solid State X-Ray Imager (Flat Panel/Digital Imager) 1

Registration details (sample)

MarketIdentifierNameClass / date
CN沪械注准20242060063平板探测器及其影像系统Class II
CN沪械注准20212060481无线数字平板探测器及其影像系统Class II
CN沪械注准20212060480无线数字平板探测器及其影像系统Class II
CN沪械注准20212060467数字化口内X射线成像系统Class II
EU06970569091075R1.5 Dental SensorClass IIa
EU06970569091051R2 Dental SensorClass IIa
EU06970569091037R1 Dental SensorClass IIa
EU06970569090559CS 6200 Digital Intraoral X-Ray SensorClass IIa
UK44905seethroughSENSORClass IIa

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