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Monitoring Lead Wires for EMG Monitoring 60" Leads Set of 2
EUDAMEDClass I (EU MDR)
Ref ELDS-BR
Identity
- Device Name
- Monitoring Lead Wires for EMG Monitoring 60" Leads Set of 2 EUDAMED
- Model / Reference
- ELDS-BR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850298007096 EUDAMED
- Basic UDI-DI
- 0850298007099H EUDAMED
- EMDN Code
- C02010401 ARRHYTHMOLOGY MULTIPOLAR DIAGNOSTIC CATHETERS, CONVENTIONAL 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
Monitoring Lead Wires for EMG Monitoring 60" Leads Set of 2 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 | 0850298007099H | 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 e4677fae-36a9-4094-8b66-37021c61cf06 61 fields · synced Jun 19, 2026