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Hyperextension ROM Knee Joint
EUDAMEDClass I (EU MDR)
Ref K001-KJ Model Orthotic Components
Identity
- Trade Name
- Hyperextension ROM Knee Joint EUDAMED
- Model / Reference
- Orthotic Components EUDAMEDK001-KJ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979221074890 EUDAMED
- Basic UDI-DI
- 697886721OC000PJ EUDAMED
- Direct Marketing DI
- 06979221074890 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 ROM Knee Joint 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 | 697886721OC000PJ | 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 (1)
- EUDAMED b88daea1-0c4d-47f0-8b3e-84d1c00d047a 61 fields · synced Jul 29, 2026