HomeChinaAGFA Healthcare (Shanghai) Co., Ltd.

AGFA Healthcare (Shanghai) Co., Ltd.

China · 上海 · medimg.agfa.com/china
✓ Record-verifiedregistrations found in 9 marketsEU SRN BE-MF-000000909Unified social credit code 913101156660790345

This company has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Canada, Singapore, Australia, Hong Kong — 9 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
2listed device types
Class I 1Class II 1Class III 0
plus 33 registration records and 35 510(k)
UKUnited KingdomMHRA PARD
2registered device records
Class IIa 2
BRBrazilANVISA
6registered devices
Class II 6
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
2registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
27active device licences
Class II 26Class III 1
39 including historic records
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
5device registrations
CLASS B 5
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
7active ARTG entries
Class I 1IIa 6
HKHong KongMDACS
2valid listings
Class II 2
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 Union138 raw hits, 136 excluded, 2 confirmed
United States33 registration records, 35 510(k), 0 PMA, 11 excluded
China0 certificates (Class III 0 / II 0 / I 0), as of 2026-09-01
United Kingdom2 confirmed, 1 excluded
Brazil6 confirmed, 3 excluded
Saudi Arabia2 confirmed, 0 excluded
Canada27 confirmed, 1 excluded
Manufacturer names merged into this page: AGFA HEALTHCARE N.V. · AGFA HEALTHCARE INC. · Agfa HealthCare GmbH · Agfa HealthCare · AGFA HEALTHCARE CORPORATION · AGFA HEALTHCARE NV

Regulatory identity

EU manufacturer SRN
BE-MF-000000909
UK responsible person
Agfa HealthCare IT UK Limited
Unified social credit code
913101156660790345
Exhibition record
CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
57
Website
medimg.agfa.com/china
Product categories
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
2007-10-15
Registered capital
USD 9,070,000
Paid-in capital
USD 9,070,000
Legal form
Limited liability company (wholly owned by a foreign corporation)
Industry classification
Wholesale trade
Last approval date
2026-07-13

Business registration data from Tianyancha, as of 2026-09-03. 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

52007
32008
32009
12010
52011
22012
22013
52014
32015
22016
22017
12018
12025

FDA listed device types

System, Image Processing, Radiological 1Template 1

Registration details (sample)

MarketIdentifierNameClass / date
EU05400874000710Class IIa
EU05400874000703Class IIa
UK41670Enterprise Imaging DesktopsClass IIa
UK41670Enterprise Imaging DesktopsClass IIa
USK252199AGFA HealthCare Enterprise Imaging2025-10-15
USK180589DR 800 with MUSICA Dynamic2018-04-05
USK172784DX-D Imaging Package2017-10-13
BR81806329002IMPAX 6.7Class II
BR81806329003ENTERPRISE IMAGING DIAGNOSTIC DESKTOPClass II
BR81806329004ENTERPRISE IMAGING XERO VIEWERClass II
SAME0000001927SFDAA00004EOS Dev
SAME0000001927SFDAA00005EOS Fix
CA30890EXHIBIT 3.1 (SOFTWARE)Class II
CA30401ADC SOLO DIGITIZERClass II
CA34872IMPAX CARDIOVASCULARClass II

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