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Unilateral OA Knee Brace II
EUDAMEDClass I (EU MDR)
Ref OTC206Model Lower Limb OrthosesRef 9053
Identity
- Trade Name
- Unilateral OA Knee Brace II EUDAMEDUnilateral OA Knee Brace EUDAMED
- Model / Reference
- Lower Limb Orthoses EUDAMEDOTC206 EUDAMED9053 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978867217036 EUDAMED06978867217029 EUDAMED
- Basic UDI-DI
- 697886721LO000R5 EUDAMED
- Direct Marketing DI
- 06978867217036 EUDAMED06978867217029 EUDAMED
- EMDN Code
- Y0699 EXTERNAL PROSTHESES AND ORTHOSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
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
Unilateral OA Knee Brace II by Medi Global Assistive Device Co., Ltd. — 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 | 697886721LO000R5 | Class I | Active |
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Manufacturer
- Manufacturer
- Medi Global Assistive Device Co., Ltd.
- EUDAMED SRN
- CN-MF-000034804
- Authorised Representative
- Humiss International B.V. NL-AR-000001490
Sources (2)
- EUDAMED 1cca6fc3-dcaf-427c-a174-51abac01e147 61 fields · synced Jul 12, 2026
- EUDAMED 1cb5cd56-ce5d-42f0-b6de-dca9fcabaa7f 61 fields · synced May 18, 2026