Identity
- Device Name
- PROFI SONIC H EUDAMED
- Model / Reference
- PROFI SONIC H EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08600102137684 EUDAMED
- Basic UDI-DI
- B-08600102137684 EUDAMED
- EMDN Code
- R060101,R060102 EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Slovenia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Profi Sonic H by Prizma Kragujevac Doo — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08600102137684 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Prizma Kragujevac Doo
- EUDAMED SRN
- RS-MF-000037752
- Authorised Representative
- Prizma GmbH DE-AR-000037217
Sources (1)
- EUDAMED d633cc26-d458-4214-8f47-7b24041fa1f1 61 fields · synced Jul 11, 2026