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Safety Belt
EUDAMEDClass I (EU MDR)
Ref B4Model B2,B4,B8,B9,B10,B11,B12Ref B2Ref B11
Identity
- Device Name
- Safety Belt EUDAMED
- Model / Reference
- B2,B4,B8,B9,B10,B11,B12 EUDAMEDB4 EUDAMEDB2 EUDAMEDB11 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974442050142 EUDAMED06974442050135 EUDAMED06974442050098 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 (3)
- EUDAMED fa834591-bcef-4873-89e4-e94a9c25fe51 61 fields · synced Oct 6, 2026
- EUDAMED c5e6a183-ce87-4d4c-983e-41d951a9c92e 61 fields · synced May 18, 2026
- EUDAMED 6963923d-734c-4216-b032-4602a8d6ddbd 61 fields · synced May 18, 2026