Identity
- Trade Name
- Sonostat EUDAMED
- Device Name
- Sonostat EUDAMED
- Model / Reference
- Sonostat touch 133 EUDAMED032-0-3000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260364810103 EUDAMED
- Basic UDI-DI
- 426036481B010XH EUDAMED
- EMDN Code
- Z120610 ULTRASOUND THERAPY EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Sonostat by Gbo Medizintechnik Ag — Class IIa — 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 | 426036481B010XH | Class IIa | Active |
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Manufacturer
- Manufacturer
- gbo Medizintechnik AG
- EUDAMED SRN
- DE-MF-000018065
Sources (1)
- EUDAMED 309842a4-72b4-41ef-b620-edb0ea0b1013 61 fields · synced Aug 4, 2026