Identity
- Trade Name
- Provox Adhesive FlexiDerm Round EUDAMED
- Device Name
- Provox Adhesive EUDAMED
- Model / Reference
- 7253ES EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07331791011351 EUDAMED
- Basic UDI-DI
- 7331791-ADH-0-000-0000-CQ EUDAMED
- Unit of Use DI
- 07331791181443 EUDAMED
- EMDN Code
- R060280 HUMIDIFICATION SYSTEMS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Category: Tracheostomy tube speech valve
Provox Adhesive FlexiDerm Round by Atos Medical AB — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 7331791-ADH-0-000-0000-CQ | Class I | Active |
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Manufacturer
- Manufacturer
- Atos Medical AB
- EUDAMED SRN
- SE-MF-000000725
Sources (1)
- EUDAMED ca41aeb4-a17c-451c-9987-e1b7472467d9 61 fields · synced Sep 18, 2026