← Back to catalogue
Sigma Safety Monitor Cable IEC ECG/EMG
EUDAMEDClass I (EU MDR)
Ref 9010-0011-06
Identity
- Device Name
- Sigma Safety Monitor Cable IEC ECG/EMG EUDAMED
- Model / Reference
- 9010-0011-06 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10850045508156 EUDAMED
- Basic UDI-DI
- 10850045508156DT 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
Sigma Safety Monitor Cable IEC ECG/EMG 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 | 10850045508156DT | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- SigmaStim Domestic LLC
- EUDAMED SRN
- US-MF-000029359
- Authorised Representative
- ICON (LR) Limited IE-AR-000006507
Sources (1)
- EUDAMED 6a922a9f-3e25-4618-bd04-4e398f3f1b93 61 fields · synced Oct 6, 2026