Identity
- Trade Name
- Nadelelektrode; ø 0,8x22mm EUDAMED
- Device Name
- Monopolar electrodes, SU EUDAMED
- Model / Reference
- 21191-312 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04050147013117 EUDAMED
- Basic UDI-DI
- 4050147Mo-Elektrode-SU-YS EUDAMED
- Direct Marketing DI
- 04050147013117 EUDAMED
- EMDN Code
- K0201010301 OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE EUDAMED
- Models / Variants
- Nadelelektrode EUDAMEDø 0, 8x22mm 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 electrode, monopolar, single-use
Nadelelektrode +1 more model by Erbe Elektromedizin GmbH — Class IIb — MDR — 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/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4050147Mo-Elektrode-SU-YS | Class IIb | Active |
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Manufacturer
- Manufacturer
- Erbe Elektromedizin GmbH
- EUDAMED SRN
- DE-MF-000005498
Sources (1)
- EUDAMED 34c21607-2ab8-4f3b-84e7-00cb055e2fbd 61 fields · synced Sep 18, 2026