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Ziehm Imaging GmbH

✓ Record-verifiedregistrations found in 12 marketsEU SRN DE-MF-000011027Unified social credit code 913100006778816635

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 12 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

3UDI-DI device records

Class IIb 3

USUnited StatesFDA openFDA

3listed device types

Class I 0Class II 3Class III 0

plus 4 registration records and 25 510(k)

UKUnited KingdomMHRA PARD

1registered device records

Class IIb 1

BRBrazilANVISA

0registered devices

1 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

6active device licences

Class III 6

10 including historic records

TWTaiwanTFDA

13valid device licences

Class II 13

SGSingaporeHSA SMDR

8device registrations

CLASS C 8

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

1active ARTG entries

IIb 1

HKHong KongMDACS

2valid listings

Class III 2

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

7active registrations

Class 2b 7

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 Union8 raw hits, 5 excluded, 3 confirmed

United States4 registration records, 25 510(k), 0 PMA, 2 excluded

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

United Kingdom1 confirmed, 1 excluded

Brazil0 confirmed, 2 excluded

Canada6 confirmed, 1 excluded

Manufacturer names merged into this page: ZIEHM IMAGING GMBH

Regulatory identity

EU manufacturer SRN: DE-MF-000011027
UK responsible person: Xograph Healthcare limited
Unified social credit code: 913100006778816635
Exhibition record: CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Business registration

Registration status: Active
Incorporated: 2008-08-27
Registered capital: USD 450,000
Paid-in capital: USD 450,000
Legal form: Limited liability company (wholly owned by a foreign corporation)
Industry classification: Wholesale trade
Last approval date: 2025-03-12
Recognitions: Micro and small enterprise

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

12005

32006

12008

22009

12013

12015

12016

22019

12020

12021

42023

32024

42025

FDA listed device types

Image-Intensified Fluoroscopic X-Ray System, Mobile 1Interventional Fluoroscopic X-Ray System 1System, X-Ray, Fluoroscopic, Image-Intensified 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	+EZIEZIEHMVISIONRB11	Ziehm Vision R	Class IIb
EU	+EZIEZIEHMVISIONRA11	Ziehm Vision R	Class IIb
EU	+EZIEZIEHM8000A11	Ziehm 8000	Class IIb
UK	37646	Mobile Radiographic/Fluoroscopic Unit (mobile C-arms)	Class IIb
US	K243646	Ziehm Solo FD	2025-03-17
US	K243735	Ziehm Vision FD	2025-03-13
US	K243303	Ziehm Vision RFD 3D	2025-01-21
CA	79615	ZIEHM VISION	Class III
CA	80151	ZIEHM VISION VARIO	Class III
CA	80154	ZIEHM VISION FD VARIO	Class III