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ROM Hinge Knee Support
EUDAMEDClass I (EU MDR)
Ref MKNNP92 (XL/UNI/BG)Model Knee Brace Series
Identity
- Trade Name
- ROM Hinge Knee Support EUDAMED
- Device Name
- Knee orthosis and tubular support bandage EUDAMED
- Model / Reference
- Knee Brace Series EUDAMEDMKNNP92 (XL/UNI/BG) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04712302980572 EUDAMED
- Basic UDI-DI
- 471230298KNR4 EUDAMED
- EMDN Code
- Y061209 KNEE ORTHOSES 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
ROM Hinge Knee Support by e-life International 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 | 471230298KNR4 | Class I | Active |
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Manufacturer
- Manufacturer
- e-life International Co., Ltd.
- EUDAMED SRN
- TW-MF-000009901
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 3cad1010-576c-49db-96a4-42b472f5ff6a 61 fields · synced Jun 18, 2026