Vi-Sealer
by Zerone Co., Ltd. 3 variants
Ref VS02-02R
VI-Sealer (VS02-02R) is a medical device (EU MDD Class IIb; EMDN category endoscopic electrosurgery electrodes) made by Zerone Co., Ltd., registered in EUDAMED on 4 May 2026 (Basic UDI-DI B-08809417424742), active as of 23 Oct 2026.
Active
CE MDD
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-08809417424742 08809417424742 | Date4 May 2026 | StatusActive |
Official records
- EUDAMED public site B-08809417424742
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Device name
- Endoscopic electrosurgical electrode
- Model / reference
- VS02-02R
- Primary DI / UDI-DI
- 08809417424742
- Basic UDI-DI
- B-08809417424742
- EMDN code
- L180602 Endoscopic electrosurgery electrodes, reusable
- Device class
- Class IIb
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- KR-MF-000014148
- Authorised representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
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