Identity
- Trade Name
- Stainless Steel Electrode FLAT BiLateral EUDAMED
- Device Name
- EEFL EUDAMED
- Model / Reference
- EEFL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850298007140 EUDAMED
- Basic UDI-DI
- 08502980071092 EUDAMED
- EMDN Code
- V9015 ELECTRODES AND PROBES CUTANEOUS CONDUCTIVE SUBSTANCES EUDAMED
Classification
- Device Class
- Class I 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
Stainless Steel Electrode FLAT BiLateral by Somatics, LLC — Class I — 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 | 08502980071092 | Class I | Active |
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Manufacturer
- Manufacturer
- Somatics, LLC
- EUDAMED SRN
- US-MF-000011550
- Authorised Representative
- FBI Medizintechnik GmbH DE-AR-000009421
Sources (1)
- EUDAMED 0d678a37-11b1-40b7-bf59-9261f2ebd974 61 fields · synced Jun 18, 2026