Identity
- Trade Name
- Kugelelektrode; ø 4mm EUDAMED
- Device Name
- Monopolar electrodes, RU EUDAMED
- Model / Reference
- 21191-124 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04050147011960 EUDAMED
- Basic UDI-DI
- B-04050147011960 EUDAMED
- EMDN Code
- L180601 OPEN ELECTROSURGERY ELECTRODES, REUSABLE EUDAMED
- Models / Variants
- Kugelelektrode EUDAMEDø 4mm 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
Kugelelektrode +1 more model by Erbe Elektromedizin GmbH — Class IIb — MDD — listed in EUDAMED — 2 models — 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-04050147011960 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Erbe Elektromedizin GmbH
- EUDAMED SRN
- DE-MF-000005498
Sources (1)
- EUDAMED a9a3542a-6b34-433d-833c-6f6b3f9480e1 61 fields · synced Oct 6, 2026