Identity
- Trade Name
- VIO® seal EUDAMED
- Device Name
- VIO® seal Electrosurgical unit EUDAMED
- Model / Reference
- 10160-020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04050147023734 EUDAMED
- Basic UDI-DI
- 4050147VIOseal-PL EUDAMED
- Direct Marketing DI
- 04050147023734 EUDAMED
- EMDN Code
- Z12010902 ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
VIO® seal by Erbe Elektromedizin GmbH — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4050147VIOseal-PL | Class IIb | Active |
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Manufacturer
- Manufacturer
- Erbe Elektromedizin GmbH
- EUDAMED SRN
- DE-MF-000005498
Sources (1)
- EUDAMED 2de90616-5dcd-47a6-bd81-13c79771b57f 61 fields · synced Oct 6, 2026