Identity
- Device Name
- Crutches EUDAMED
- Model / Reference
- UN8001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974795468014 EUDAMED
- Basic UDI-DI
- 697479546UN8000US EUDAMED
- Direct Marketing DI
- 06974795468014 EUDAMED
- EMDN Code
- Y12030602 CRUTCHES WITH ANTIBRACHIAL SUPPORT EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Introducing the Crutches medical device, designed to provide a safe and effective alternative for patients with mobility issues. This innovative device features advanced technology and user-friendly design, making it an ideal solution for healthcare professionals and patients alike.
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 | 697479546UN8000US | Class I | Active |
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Manufacturer
- Manufacturer
- Zhenjiang U-Nurse Medical Equipment Co., Ltd
- EUDAMED SRN
- CN-MF-000013494
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 04ec999b-695d-4e44-813f-a0baa7b2aa0b 61 fields · synced Jun 25, 2026