Identity
- Trade Name
- 2 Pedal-Fußsch. VIO®; m.Bügel EUDAMED
- Device Name
- Footswitch, electrosurgery stystems EUDAMED
- Model / Reference
- 20189-301 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04050147010130 EUDAMED
- Basic UDI-DI
- B-04050147010130 EUDAMED
- EMDN Code
- Z12010902 ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE EUDAMED
- Models / Variants
- 2 Pedal-Fußsch. VIO® EUDAMEDm.Bügel 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
Category: Foot-switch, electrical
2 Pedal-Fußsch. VIO® +1 more model by Erbe Elektromedizin GmbH — Class IIb — MDD — listed in EUDAMED — 2 models — regulatory data on deviCERTS
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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-04050147010130 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Erbe Elektromedizin GmbH
- EUDAMED SRN
- DE-MF-000005498
Sources (1)
- EUDAMED 83a07b13-e455-4ae1-8f8c-cf33cc45241c 61 fields · synced Sep 19, 2026