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Telescopic ROM Knee Brace with Silicone Pad
EUDAMEDClass I (EU MDR)
Ref K008Model Lower Limb OrthosesRef 9010
Identity
- Trade Name
- Telescopic ROM Knee Brace with Silicone Pad EUDAMEDTelescopic ROM Knee Brace EUDAMED
- Model / Reference
- Lower Limb Orthoses EUDAMEDK008 EUDAMED9010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978867217012 EUDAMED06978867216978 EUDAMED
- Basic UDI-DI
- 697886721LO000R5 EUDAMED
- Direct Marketing DI
- 06978867217012 EUDAMED06978867216978 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
Telescopic ROM Knee Brace with Silicone Pad 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 08358892-346a-47ed-83db-5264413dfd05 61 fields · synced Oct 6, 2026
- EUDAMED 0bfc52a1-0a44-446e-9446-516b3c9b9f7d 61 fields · synced May 18, 2026