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Carestream Health

✓ Record-verifiedregistrations found in 13 marketsEU SRN US-MF-000050774Unified social credit code 91310000676282888K

This company has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 13 overseas markets. No China NMPA registrations were found.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

0China registrations

as of 2026-09-01

EUEuropean UnionEUDAMED

2UDI-DI device records

Class IIa 2

USUnited StatesFDA openFDA

22listed device types

Class I 8Class II 14Class III 0

plus 41 registration records and 54 510(k), 5 PMA

UKUnited KingdomMHRA PARD

19registered device records

Class I 6Class IIa 8Class IIb 5

BRBrazilANVISA

23registered devices

Class I 5Class II 18

26 including historic records

SASaudi ArabiaSFDA

1registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

50active device licences

Class II 43Class III 7

58 including historic records

TWTaiwanTFDA

12valid device licences

Class I 5Class II 7

SGSingaporeHSA SMDR

19device registrations

CLASS B 10CLASS C 9

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

7active ARTG entries

Class I 1IIa 3IIb 2Class Im (measuring) 1

HKHong KongMDACS

3valid listings

Class III 3

ILIsraelAMAR

7registrations

RURussiaRoszdravnadzor

31active registrations

Class 1 2Class 2a 14Class 2b 15

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 Union163 raw hits, 161 excluded, 2 confirmed

United States41 registration records, 54 510(k), 5 PMA, 6 excluded

China0 certificates (Class III 0 / II 0 / I 0), as of 2026-09-01

United Kingdom19 confirmed, 1 excluded

Brazil23 confirmed, 5 excluded

Saudi Arabia1 confirmed, 1 excluded

Canada50 confirmed, 3 excluded

Manufacturer names merged into this page: Carestream Health, Inc · CARESTREAM HEALTH, INC., GLOBAL R&D CENTER · Carestream Health, Inc. · CARESTREAM HEALTH, INC. · CARESTREAM HEALTH INC. · CARESTREAM HEALTH, INC

Regulatory identity

EU manufacturer SRN: US-MF-000050774
EU authorised representative: CARESTREAM HEALTH ITALIA S.R.L.
UK responsible person: Qserve Group UK, Ltd.
Unified social credit code: 91310000676282888K
Exhibition record: CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Business registration

Registration status: Active
Incorporated: 2008-07-10
Registered capital: USD 2,000,000
Paid-in capital: USD 2,000,000
Legal form: Limited liability company (wholly owned by a HK/Macao/Taiwan corporation)
Industry classification: Retail trade
Last approval date: 2026-05-28

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

22008

42009

12010

42011

42012

22013

32014

62015

32016

32017

42018

52019

42020

12021

22022

12023

22024

12025

22026

FDA listed device types

showing 8 of 22

Light, Catheter, Fiberoptic, Glass, Ureteral 1System, Image Processing, Radiological 1Solid State X-Ray Imager (Flat Panel/Digital Imager) 1System, X-Ray, Mobile 1Table, Radiographic, Non-Tilting, Powered 1Table, Radiologic 1Full Field Digital, System, X-Ray, Mammographic 1Light Source, Fiberoptic, Routine 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	60889976709832	Lux HD 43	Class IIa
EU	60889976709825	Lux HD 35 Detector	Class IIa
UK	17904	Classic CR System	Class IIa
UK	40978	D-Speed	Class IIa
UK	40977	X-OMAT DBF	Class IIa
US	K253185	Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System	2026-03-11
US	K250954	DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector	2026-01-20
US	K251168	Image Suite	2025-09-04
BR	80378750061	Filme Analógico para Aplicações Radiográficas	Class II
BR	80378750052	SOFTWARE IMAGESUITE	Class I
BR	80378750037	Filmes para Impressão de Imagens a Laser Trimax	Class II
SA	ME0000002364SFDAA00008	SPT2 Radiographic Table	—
CA	61892	X-RAY GENERATORS	Class II
CA	62643	COMPUTED RADIOGRAPHY SYSTEMS	Class II
CA	69041	VITA CR SYSTEMS	Class II