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Hyperextension Telescopic ROM Knee Brace
EUDAMEDClass I (EU MDR)
Ref K001Model Lower Limb OrthosesRef K002
Identity
- Trade Name
- Hyperextension Telescopic ROM Knee Brace EUDAMEDTelescopic ROM Knee Orthosis EUDAMED
- Model / Reference
- Lower Limb Orthoses EUDAMEDK001 EUDAMEDK002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979221074708 EUDAMED06978867217005 EUDAMED
- Basic UDI-DI
- 697886721LO000R5 EUDAMED
- Direct Marketing DI
- 06979221074708 EUDAMED06978867217005 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
Hyperextension Telescopic ROM Knee Brace 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 64974ea2-c206-458d-a7eb-7b49ee3f9d84 61 fields · synced Jul 20, 2026
- EUDAMED b5442325-ddc5-4770-846e-5eb96b6d6b27 61 fields · synced May 18, 2026