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Winelec
EUDAMEDClass IIa (EU MDR)
Ref CT-314B0Model WHF-314/PRESS 4Ref CT-1PMB0Model POWER-Q1000PREMIUM/PREMIUM 4Ref CT-Q80B0Model POWER-Q8120/ POWER-Q8060/PREMIUM6Ref CT-PB0B0Model WPB202
Identity
- Trade Name
- Winelec EUDAMED
- Device Name
- Compressible Limb and Circualtion Therapy System EUDAMEDPOWER-Q8120/ POWER-Q8060/PREMIUM6 EUDAMED
- Model / Reference
- WHF-314/PRESS 4 EUDAMEDCT-314B0 EUDAMEDPOWER-Q1000PREMIUM/PREMIUM 4 EUDAMEDCT-1PMB0 EUDAMEDPOWER-Q8120/ POWER-Q8060/PREMIUM6 EUDAMEDCT-Q80B0 EUDAMEDWPB202 EUDAMEDCT-PB0B0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809277420007 EUDAMED08809277420168 EUDAMED18809277423388 EUDAMED08809277420434 EUDAMED08809277421554 EUDAMED
- Basic UDI-DI
- 880927742W314XGZ EUDAMED880927742P10PXGJ EUDAMED880927742P800XF6 EUDAMED880927742PRB1XPD EUDAMED
- EMDN Code
- Z120607 PNEUMATIC COMPRESSION EQUIPMENT EUDAMEDZ120619 PARAFFIN THERAPY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMEDItaly EUDAMEDCzechia 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 | 880927742W314XGZ | 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 (5)
- EUDAMED 8214c414-0e62-4c54-8451-860283ad1110 61 fields · synced Aug 2, 2026
- EUDAMED 87a3b177-246f-4c5d-9aa9-7b42281247b0 61 fields · synced May 16, 2026
- EUDAMED 806d57ac-56db-4671-8308-2f01f3f5948f 61 fields · synced May 17, 2026
- EUDAMED 7690dbc5-7b47-48d2-9c6e-a955d15bb601 61 fields · synced May 17, 2026
- EUDAMED 030fad9a-d241-4e63-8c28-60d43154022b 61 fields · synced May 19, 2026