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Home›Fritz Stephan GmbH Medizintechnik

Fritz Stephan GmbH Medizintechnik

✓ Record-verifiedregistrations found in 8 marketsEU SRN DE-MF-000007591

This company has registrations in European Union, United Kingdom, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 8 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
7UDI-DI device records
Class IIa 1Class IIb 6
USUnited StatesFDA openFDA
0listed device types
Class I 0Class II 0Class III 0
plus 0 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
7registered device records
Class IIb 7
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
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
3device registrations
CLASS B 2CLASS C 1
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
5active ARTG entries
Class I 1IIa 1IIb 3
HKHong KongMDACS
1valid listings
Class III 1
ILIsraelAMAR
3registrations
RURussiaRoszdravnadzor
8active registrations
Class 2a 4Class 2b 4
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 Union7 raw hits, 0 excluded, 7 confirmed
United Kingdom7 confirmed, 1 excluded

Regulatory identity

EU manufacturer SRN
DE-MF-000007591
UK responsible person
MEDACX Limited
Exhibition record
CMEF 87th (Spring 2023, Shanghai)

Company information

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.

Registration details (sample)

MarketIdentifierNameClass / date
EU04064428001298—Class IIb
EU04064428001281—Class IIb
EU04064428001274—Class IIb
EU04064428001267—Class IIb
UK42411EVEClass IIb
UK42411EVEClass IIb
UK42411EVAClass IIb

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