HomeGermanyOPED GmbH

OPED GmbH

Germany · Valley · www.oped-international.com
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, United Kingdom, Saudi Arabia, Taiwan, Singapore, 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
0UDI-DI device records
USUnited StatesFDA openFDA
3listed device types
Class I 3Class II 0Class III 0
plus 3 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
3registered device records
Class I 2Class IIa 1
BRBrazilANVISA
0registered devices
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
0active device licences
TWTaiwanTFDA
3valid device licences
Class I 1Class II 2
SGSingaporeHSA SMDR
1device registrations
CLASS B 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
6active ARTG entries
Class I 5IIa 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
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 Union60,610 raw hits, 100 excluded, 0 confirmed. Large result set — only the first 300 verified
United States3 registration records, 0 510(k), 0 PMA, 2 excluded
United Kingdom3 confirmed, 17 excluded
Saudi Arabia2 confirmed, 0 excluded
Manufacturer names merged into this page: OPED GmbH

Regulatory identity

UK responsible person
Qserve Group UK, Ltd.

Company information

Country
Germany
City
Valley
Website
www.oped-international.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesOrthopaedics, Trauma & RehabilitationTrauma systems

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

LEI
529900MCK69ET8MGBM60
Registration status
Active
Legal form
Gesellschaft mit beschränkter Haftung (GmbH)
Incorporated
1992-04-13
Registered address
Medizinpark 1, Valley, 83626
Registration authority
Commercial Register, no. HRB 98589
Registry record updated
2026-06-26

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

FDA listed device types

Goniometer, Ac-Powered 1Orthosis, Limb Brace 1Orthosis, Corrective Shoe 1

Registration details (sample)

MarketIdentifierNameClass / date
UK41435EVENupClass I
UK44784VADOplexClass IIa
UK44784VADOplex Calf PadClass I
SAME0000004552SFDAA00017VADO Foot Pad
SAME0000004552SFDAA00018Calf Pad

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