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Bedrail
EUDAMEDClass I (EU MDR)
Ref SC-BR04Model SC-BR01,SC-BR02,SC-BR03,SC-BR04,SC-BR06,SC-BR06,SC-BR07, SC-BR08,SC-BR09,SC-BR10,SC-BR11,SC-BR12,SC-BR13,SC-BR14, SC-BR15,SC-BR16,SC-BR17,SC-BR18,SC-BR19,SC-BR20,SC-BR21
Identity
- Device Name
- Bedrail EUDAMED
- Model / Reference
- SC-BR01,SC-BR02,SC-BR03,SC-BR04,SC-BR06,SC-BR06,SC-BR07, SC-BR08,SC-BR09,SC-BR10,SC-BR11,SC-BR12,SC-BR13,SC-BR14, SC-BR15,SC-BR16,SC-BR17,SC-BR18,SC-BR19,SC-BR20,SC-BR21 EUDAMEDSC-BR04 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974576188346 EUDAMED
- Basic UDI-DI
- 697457618BEDRAILXY EUDAMED
- EMDN Code
- Y1899 AIDS, FURNITURE AND HOME AIDS FOR PERSONS WITH DISABILITIES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Bedrail by Foshan Suncare Medical Products 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 | 697457618BEDRAILXY | Class I | Active |
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Manufacturer
- Manufacturer
- Foshan Suncare Medical Products Co., Ltd
- EUDAMED SRN
- CN-MF-000008985
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 4d4b35b9-1aa6-4acd-90f2-310a9644e9f4 61 fields · synced Oct 6, 2026