Single use Sterile Plasma Bipolar Electrode
by Simai Co., Ltd. China EUDAMED
Ref SM01-001A...43 models totalModel SM01-001A/SM01-002A/SM01-003A/SM01-004A/SM11-001A/SM11-002A......43 model total EMDN K0201010302
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-06970197920648 | Date11 Nov 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDD Expiring
Specification
- Device Name
- Single use Sterile Plasma Bipolar Electrode
- Model / Reference
- SM01-001A/SM01-002A/SM01-003A/SM01-004A/SM11-001A/SM11-002A......43 model total, SM01-001A...43 models total
- Primary DI / UDI-DI
- 06970197920648
- Basic UDI-DI
- B-06970197920648
- EMDN Code
- K0201010302 Lapar and thoracoscopic electrosurgery electrodes, single-use
- Device Class
- Class IIb
- Market of Registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- CN-MF-000021302
- Authorised representative
- Wellkang Ltd XI-AR-000001836
Other devices from Simai Co., Ltd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (10)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 68b731bd-5d6f-456a-8b29-ad2fef8fcd56