Identity
- Trade Name
- Provox Swab XtraLarge EUDAMED
- Device Name
- Provox Swab EUDAMED
- Model / Reference
- 8258 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07331791012730 EUDAMED
- Basic UDI-DI
- 7331791-GEN-A-000-0002-EC EUDAMED
- Unit of Use DI
- 07331791181344 EUDAMED
- EMDN Code
- R01058099 TRACHEOSTOMY AND LARYNGECTOMY CANNULAS - VARIOUS ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Provox Swab XtraLarge by Atos Medical AB — 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 | 7331791-GEN-A-000-0002-EC | Class I | Active |
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Manufacturer
- Manufacturer
- Atos Medical AB
- EUDAMED SRN
- SE-MF-000000725
Sources (1)
- EUDAMED 9221ff04-28fe-444c-a28a-0253d53e912b 61 fields · synced Aug 4, 2026