Identity
- Device Name
- Safety Belt EUDAMED
- Model / Reference
- B2,B4,B8,B9,B10,B11,B12 EUDAMEDB12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974442050074 EUDAMED
- Basic UDI-DI
- 697444205SB001DE EUDAMED
- EMDN Code
- Y122406 BELTS, SEATS AND ARMRESTS FOR WHEELCHAIRS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
Safety Belt by Jiangsu Rixin 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 | 697444205SB001DE | Class I | Active |
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Manufacturer
- Manufacturer
- Jiangsu Rixin Medical Equipment Co., Ltd.
- EUDAMED SRN
- CN-MF-000008761
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED d38d9135-ea63-40cc-98a4-95f03e4cbcdc 61 fields · synced Jun 19, 2026