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spECTrum EEG/ECG Five-Lead Set-IEC (replacement)
EUDAMEDClass I (EU MDR)
Ref 9010-0011-12
Identity
- Device Name
- spECTrum EEG/ECG Five-Lead Set-IEC (replacement) EUDAMED
- Model / Reference
- 9010-0011-12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10850045508309 EUDAMED
- Basic UDI-DI
- 10850045508309DU EUDAMED
- EMDN Code
- Z12109002 ELECTROCONVULSIVE THERAPY (ECT) EQUIPMENT EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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
spECTrum EEG/ECG Five-Lead Set-IEC (replacement) by SigmaStim Domestic 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 | 10850045508309DU | Class I | Active |
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Manufacturer
- Manufacturer
- SigmaStim Domestic LLC
- EUDAMED SRN
- US-MF-000029359
- Authorised Representative
- ICON (LR) Limited IE-AR-000006507
Sources (1)
- EUDAMED f7d1ed9a-19c8-4360-bd65-94f1dd03d330 61 fields · synced Jun 19, 2026