Identity
- Trade Name
- Vi-Sealer EUDAMED
- Device Name
- Endoscopic electrosurgical electrode EUDAMED
- Model / Reference
- VS02-02R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809417424742 EUDAMED
- Basic UDI-DI
- B-08809417424742 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-08809417424742 | 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 (1)
- EUDAMED 602f3619-83f4-44ef-ace5-36bc78046957 61 fields · synced Jun 18, 2026