Identity
- Trade Name
- Einmal-Elektrodengriff EUDAMED
- Device Name
- Electrosurgical pencils, SU EUDAMED
- Model / Reference
- 20190-108 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04050147003019 EUDAMED
- Basic UDI-DI
- B-04050147003019 EUDAMED
- EMDN Code
- K0201010501 OPEN ELECTROSURGERY HANDPIECES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
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: Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
Einmal-Elektrodengriff by Erbe Elektromedizin GmbH — Class IIb — MDD — listed in EUDAMED — 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-04050147003019 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Erbe Elektromedizin GmbH
- EUDAMED SRN
- DE-MF-000005498
Sources (1)
- EUDAMED b5f3658a-6c5c-47c9-bbef-c35e74cb4081 61 fields · synced Oct 6, 2026