Identity
- Device Name
- PROFI SONIC EUDAMED
- Model / Reference
- PROFI SONIC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08600102137608 EUDAMED
- Basic UDI-DI
- B-08600102137608 EUDAMED
- EMDN Code
- R060101 COLD NEBULISATION SYSTEMS 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 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-08600102137608 | 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 dd6874f8-cb11-41f4-aaf2-6eecd012df5a 61 fields · synced Jun 18, 2026