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Winner
EUDAMEDClass I (EU MDR)
Ref N/AModel SB-1, SB-2, SB-3, SB-3A, SB-3C, SB-4, SB-5, SB-5A1, SB-5A2, SB-5B1, SB-5B2, SB-6, SB-7, SB-8, SB-9S, SB-9M, SB-9L.
Identity
- Trade Name
- WINNER EUDAMED
- Device Name
- SPINE BOARD EUDAMED
- Model / Reference
- SB-1, SB-2, SB-3, SB-3A, SB-3C, SB-4, SB-5, SB-5A1, SB-5A2, SB-5B1, SB-5B2, SB-6, SB-7, SB-8, SB-9S, SB-9M, SB-9L. EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976160190018 EUDAMED
- Basic UDI-DI
- 697616019SB001F2 EUDAMED
- Direct Marketing DI
- 06976160190018 EUDAMED
- EMDN Code
- V08050101 GENERIC USE STRETCHERS 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
Winner by Hangzhou Winner Kayak Manufacturing 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 | 697616019SB001F2 | Class I | Active |
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Manufacturer
- Manufacturer
- Hangzhou Winner Kayak Manufacturing Co., Ltd
- EUDAMED SRN
- CN-MF-000033678
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (2)
- EUDAMED 891e1cf8-f9db-4bbe-8f5e-cdb6d842bb5f 61 fields · synced Jun 19, 2026
- EUDAMED 891e1cf8-f9db-4bbe-8f5e-cdb6d842bb5f-1 61 fields · synced Jun 9, 2026