Identity
- Device Name
- Crutches EUDAMED
- Model / Reference
- UN8003 EUDAMEDUN8005 EUDAMEDUN8002 EUDAMEDUN8004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974795468038 EUDAMED06974795468052 EUDAMED06974795468021 EUDAMED06974795468045 EUDAMED
- Basic UDI-DI
- 697479546UN8000US EUDAMED
- Direct Marketing DI
- 06974795468038 EUDAMED06974795468052 EUDAMED06974795468021 EUDAMED06974795468045 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
Crutches by Zhenjiang U-Nurse Medical Equipment 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 | 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 (4)
- EUDAMED 8adf4acd-9951-44cb-86a8-211f3112d395 61 fields · synced Oct 6, 2026
- EUDAMED f6f05e97-2260-4d3e-be7e-79f0c251a7b3 61 fields · synced May 17, 2026
- EUDAMED 1f774ac8-af28-453b-8e5d-fd59fd100e16 61 fields · synced May 18, 2026
- EUDAMED e71c7877-32d4-4364-9cde-a24a32d95161 61 fields · synced May 18, 2026