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spECTrum Dual Hand-Held w/o Remote (replacement)
EUDAMEDClass I (EU MDR)
Ref 9438-0078-02
Identity
- Device Name
- spECTrum Dual Hand-Held w/o Remote (replacement) EUDAMED
- Model / Reference
- 9438-0078-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850045508357 EUDAMED
- Basic UDI-DI
- 00850045508357CU 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 Dual Hand-Held w/o Remote (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 | 00850045508357CU | 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 c9032dd8-c966-40d8-9c69-805f2bde8f8d 61 fields · synced Jul 10, 2026