Identity
- Trade Name
- SigmaStim Sigma FDA UDI
- Generic Name
- Electroconvulsive therapy system FDA UDI
- Device Name
- SigmaStim Σigma 200J EUDAMED
- Model / Reference
- 9438-5001 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850045508005 EUDAMED00850045508012 FDA UDI
- Basic UDI-DI
- B-00850045508005 EUDAMED
- 510(k) Number
- K192834 FDA UDI
- FDA Product Code
- QGH FDA UDI
- EMDN Code
- Z12109002 ELECTROCONVULSIVE THERAPY (ECT) EQUIPMENT EUDAMED
- GMDN Term
- Electroconvulsive therapy system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 882.5940 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
SigmaStim Σigma 200J by SigmaStim Domestic LLC — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00850045508005 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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 (2)
- EUDAMED f6316ede-69b4-4e0c-9e77-046d1007b068 61 fields · synced Jun 19, 2026
- FDA UDI 314fc567-1657-48a6-a87e-e2964ca61829 33 fields · synced May 30, 2026