Winelec
by Wonjin Mulsan Co., Ltd. South Korea EUDAMED
Ref CT-PB0B0Model WPB202
EMDN Z120619
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number2023-MDR/QS-059 | Date6 Dec 2023 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- 2023-MDR/QS-059 Issued
Quality management system EU MDR
- Notified body
- 3EC International a.s. 2265
- Issued
- 6 Dec 2023
- Expires
- 6 Dec 2028
Specification
- Model / Reference
- WPB202, CT-PB0B0
- Primary DI / UDI-DI
- 08809277420434
- Basic UDI-DI
- 880927742PRB1XPD
- EMDN Code
- Z120619 Paraffin therapy systems
- Device Class
- Class IIa
- Market of Registration
- Czechia
Manufacturer details
- EUDAMED SRN
- KR-MF-000001420
- Authorised representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Other devices from Wonjin Mulsan Co.ltd
Properties & raw data
Show properties, registry sources and raw records
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 7690dbc5-7b47-48d2-9c6e-a955d15bb601