HomeGermanyOsypka GmbH

Osypka GmbH

Germany · Rheinfelden · www.osypka.de
✓ Record-verifiedregistrations found in 7 marketsEU SRN DE-MF-000005610

This company has registrations in European Union, United States, United Kingdom, Brazil, Taiwan, Australia, Israel — 7 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
126UDI-DI device records
Class I 30Class IIb 1Class III 95
USUnited StatesFDA openFDA
4listed device types
Class I 0Class II 3Class III 1
plus 4 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
6registered device records
Class I 2Class III 4
BRBrazilANVISA
1registered devices
Class II 1
2 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
1valid device licences
Class II 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
2active ARTG entries
Class Is (sterile) 2
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
5registrations
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 Union126 raw hits, 0 excluded, 126 confirmed
United States4 registration records, 1 510(k), 0 PMA, 4 excluded
United Kingdom6 confirmed, 1 excluded
Brazil1 confirmed, 2 excluded
Canada0 confirmed, 2 excluded
Manufacturer names merged into this page: OSYPKA GmbH · OSYPKA AG

Regulatory identity

EU manufacturer SRN
DE-MF-000005610
UK responsible person
Dot Medical Ltd

Company information

Country
Germany
City
Rheinfelden
Website
www.osypka.de
Product categories
Manufacturing, Lifecycle & Obsolescence ManagementCDMO (Contract Development and Manufacturing Organization)General Product Development, Development & Design Transfer

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

Legal name
OSYPKA AG
LEI
9676005LEE5I83CXJ344
Registration status
Active
Legal form
Aktiengesellschaft (AG)
Incorporated
2010-08-04
Registered address
Earl-H.-Wood-Str. 1, Rheinfelden, 79618
Registration authority
Commercial Register, no. HRB 705638
Registry record updated
2024-12-15

Business registration data from GLEIF, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

12024 · K232261

FDA listed device types

Ureteroscope And Accessories, Flexible/Rigid 1Electrode, Pacemaker, Temporary 1Implanted Tibial Electrical Urinary Continence Device 1Cardiac Ablation Percutaneous Catheter 1

Registration details (sample)

MarketIdentifierNameClass / date
EU04044508109670VACS III 10.0 x 40Class III
EU04044508117743VACS III 30.0 x 60Class III
EU04044508117736VACS III 30.0 x 40Class III
EU04044508117729VACS III 28.0 x 60Class III
UK61785CerablateClass III
UK61785Magic Magnetic Interventional Ablation CatheterClass III
UK17453Percutaneous Transluminal Valvuloplasty Catheter Class III
USK232261TME Temporary Myocardial Electrode2024-04-26
BR80224390263CABO DO PACIENTE OSYPKA PARA CATETER DE ABLAÇÃOClass II

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