Identity
- Trade Name
- Vi-Sealer EUDAMED
- Device Name
- Endoscopic electrosurgical electrode EUDAMED
- Model / Reference
- VS01-02R EUDAMEDVS01-01R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809417424728 EUDAMED08809417424711 EUDAMED
- Basic UDI-DI
- B-08809417424728 EUDAMEDB-08809417424711 EUDAMED
- EMDN Code
- L180602 ENDOSCOPIC ELECTROSURGERY ELECTRODES, REUSABLE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Vi-Sealer by Zerone Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08809417424728 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Zerone Co., Ltd.
- EUDAMED SRN
- KR-MF-000014148
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED 37d066f8-15cf-47be-bcb3-300be6950392 61 fields · synced Jul 11, 2026
- EUDAMED 9778c6d0-bdc4-4a1f-b128-a8f197a4a9fb 61 fields · synced May 18, 2026