Identity
- Trade Name
- Prevounce Platform EUDAMED
- Device Name
- Prevounce Platform EUDAMED
- Model / Reference
- Prevounce Platform EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00860011521297 EUDAMED
- Basic UDI-DI
- 08600115212PrevounceFL EUDAMED
- Direct Marketing DI
- 00860011521297 EUDAMED
- EMDN Code
- V92 MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Ireland 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
Prevounce Platform by Prevounce Health, Inc — Class I — 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 | 08600115212PrevounceFL | Class I | Active |
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Manufacturer
- Manufacturer
- Prevounce Health Inc
- EUDAMED SRN
- US-MF-000053810
- Authorised Representative
- SigmaTech Nordic ApS DK-AR-000039264
Sources (1)
- EUDAMED 9f53128f-356d-4fe1-a25e-530b68e88c13 61 fields · synced Jun 18, 2026