HomeChinaCareray Digital Medical Technology Co., Ltd.

Careray Digital Medical Technology Co., Ltd.

China · 苏州 · www.careray.cn
✓ Record-verifiedregistrations found in 6 marketsEU SRN CN-MF-000007229Unified social credit code 913205946617779330

This company holds 5 NMPA certificates in China and has registrations in European Union, United States, Brazil, Canada, Taiwan — 5 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
5China registrations
Class II 5
as of 2026-09-04
EUEuropean UnionEUDAMED
17UDI-DI device records
Class IIa 17
USUnited StatesFDA openFDA
2listed device types
Class I 0Class II 2Class III 0
plus 13 registration records and 3 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
3registered devices
Class II 3
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
5active device licences
Class II 5
9 including historic records
TWTaiwanTFDA
1valid device licences
Class II 1
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 Union17 raw hits, 0 excluded, 17 confirmed
United States13 registration records, 3 510(k), 0 PMA, 1 excluded
China5 certificates (Class III 0 / II 5 / I 0), as of 2026-09-04
Brazil3 confirmed, 0 excluded
Canada5 confirmed, 0 excluded
Manufacturer names merged into this page: CARERAY DIGITAL MEDICAL TECHNOLOGY CO., LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000007229
EU authorised representative
Lotus NL B.V.
Unified social credit code
913205946617779330
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai)

Company information

Country
China
Social-insurance enrolees
192
Annual revenue
RMB 100–500M
Website
www.careray.cn

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
2007-05-23
Registered capital
CNY 88,129,027
Paid-in capital
CNY 88,129,027
Legal form
Joint-stock limited company (foreign-invested, listed)
Industry classification
Special-purpose equipment manufacturing
Last approval date
2026-08-19
Recognitions
Micro and small enterpriseNational High-Tech EnterprisePrivate technology enterpriseSRDI SMEGazelle enterpriseRecognised enterprise technology centreAbove-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 510(k) clearances by year

22022 · K223687
12023 · K232058

FDA listed device types

Solid State X-Ray Imager (Flat Panel/Digital Imager) 1System, X-Ray, Fluoroscopic, Image-Intensified 1

Registration details (sample)

MarketIdentifierNameClass / date
CN苏械注准20252060537牙科数字化X射线成像系统Class II
CN苏械注准20192060816X射线成像系统Class II
CN苏械注准20182060781X射线成像系统Class II
CN苏械注准20182060780数字平板探测器Class II
EU06970597830752EverestView 4343XClass IIa
EU06970597832022YosemiteView 4343WClass IIa
EU06970597831049YosemiteView 3643WClass IIa
EU06970597830479CareView 3600RFClass IIa
USK232058YosemiteView 4343W/YosemiteView 3643W2023-08-03
USK223687X-ray Flat Panel Detectors (EverestView 4343X)2022-12-30
USK221549X-ray Flat Panel Detectors (CareView 1800 RF)2022-08-01
BR80117580653Detectores de Painéis Planos de Raio-XClass II
BR80117580655Detectores de Painéis Planos de Raio-XClass II
BR80117589151Detectores de Painéis Planos de Raio-XClass II
CA96952CAREVIEW 1500CW X-RAY FLAT PANEL DETECTORClass II
CA97158CAREVIEW 1500C/CAREVIEW 1500L X-RAY FLAT PANEL DETECTORClass II
CA97159CAREVIEW 1800L X-RAY FLAT PANEL DETECTORClass II

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