Identity
- Trade Name
- Thymatron System IV EUDAMEDThymatron IV FDA UDI
- Generic Name
- Electroporation therapy system generator FDA UDI
- Device Name
- Thymatron System IV EUDAMEDElectroconvulsive Therapy Instrument FDA UDI
- Model / Reference
- EDIV EUDAMEDSystem IV FDA UDI
- Description
- Electroconvulsive Therapy Instrument FDA UDI
Identifiers
- Catalog Number
- EDIV FDA UDI
- Primary DI / UDI-DI
- 00850298007003 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00850298007003 EUDAMED
- FDA Product Code
- GXC FDA UDI
- EMDN Code
- Z12109002 ELECTROCONVULSIVE THERAPY (ECT) EQUIPMENT EUDAMED
- GMDN Term
- Electroporation therapy system generator FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass III FDA UDI
- Regulation Number
- 882.5940 FDA UDI
- Market of Registration
- Germany 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Weight — 22 Pound FDA UDIDepth — 5.25 Inch FDA UDIHeight — 13 Inch FDA UDIWidth — 18 Inch FDA UDI
Thymatron System IV by Somatics, 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-00850298007003 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Somatics, LLC
- EUDAMED SRN
- US-MF-000011550
- Authorised Representative
- FBI Medizintechnik GmbH DE-AR-000009421
Sources (2)
- EUDAMED 9bc33612-7088-4ef9-b7b3-c2bada438f20 61 fields · synced Jun 18, 2026
- FDA UDI 95c5623a-85fe-45ca-9b63-d6cadb1bcad0 36 fields · synced May 30, 2026