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Winelec
EUDAMEDClass IIa (EU MDR)
Ref CT-Q80B0Model POWER-Q8120/ POWER-Q8060/PREMIUM6
Identity
- Trade Name
- Winelec EUDAMED
- Device Name
- POWER-Q8120/ POWER-Q8060/PREMIUM6 EUDAMED
- Model / Reference
- POWER-Q8120/ POWER-Q8060/PREMIUM6 EUDAMEDCT-Q80B0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809277420182 EUDAMED
- Basic UDI-DI
- 880927742P800XF6 EUDAMED
- EMDN Code
- Z120607 PNEUMATIC COMPRESSION EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
Winelec by Wonjin Mulsan Co.ltd — Class IIa — 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 | 880927742P800XF6 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Wonjin Mulsan Co., Ltd.
- EUDAMED SRN
- KR-MF-000001420
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED bb99131e-812c-46de-9288-77eca9df25cb 61 fields · synced Jun 18, 2026