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Open Knee Brace
EUDAMEDClass I (EU MDR)
Ref 2029-BG-S-1Ref 2029-BG-M-1Ref 2029-BG-L-1
Identity
- Trade Name
- Open Knee Brace EUDAMED
- Device Name
- LOWER EXTREMITY ORTHOSES EUDAMED
- Model / Reference
- 2029-BG-S-1 EUDAMED2029-BG-M-1 EUDAMED2029-BG-L-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719863693705 EUDAMED04719863693712 EUDAMED04719863693729 EUDAMED
- Basic UDI-DI
- 471986369CL102DF EUDAMED
- EMDN Code
- Y061299 LOWER EXTREMITY ORTHOSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Open Knee Brace by OPPO Medical Corp. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 471986369CL102DF | Class I | Active |
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Manufacturer
- Manufacturer
- OPPO Medical Corp.
- EUDAMED SRN
- TW-MF-000005201
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (3)
- EUDAMED 5e4cec5b-19a4-4fd3-b24c-aa6c95ccf2df 61 fields · synced Jul 22, 2026
- EUDAMED c115cd6a-6cf8-4e41-8f4f-ab60bc3728ce 61 fields · synced May 17, 2026
- EUDAMED 3bc5eb1d-f21e-4691-b315-91ea159ebcad 61 fields · synced May 18, 2026