Identity
- Trade Name
- Provox BasePlate Adaptor EUDAMEDFDA UDI
- Generic Name
- Tracheostoma protective filter FDA UDI
- Device Name
- Provox BasePlate Adaptor EUDAMEDThe Provox BasePlate Adaptor is an accessory product for rehabilitation after total laryngectomy. It allows attaching medical devices with ISO 15mm standard connector to a tracheostoma by fitting it into a Provox Adhesive base plate, Provox LaryButton or Provox LaryTube. A typical example would be to attach an HME with built-in oxygen adapter (TrachPhone). For single patient use. FDA UDI
- Model / Reference
- 7263 EUDAMEDFDA UDI
- Description
- The Provox BasePlate Adaptor is an accessory product for rehabilitation after total laryngectomy. It allows attaching medical devices with ISO 15mm standard connector to a tracheostoma by fitting it into a Provox Adhesive base plate, Provox LaryButton or Provox LaryTube. A typical example would be to attach an HME with built-in oxygen adapter (TrachPhone). For single patient use. FDA UDI
Identifiers
- Catalog Number
- 7263 FDA UDI
- Primary DI / UDI-DI
- 07331791001697 EUDAMEDFDA UDI
- Basic UDI-DI
- 7331791-HME-A-000-0003-F5 EUDAMED
- 510(k) Number
- K014102 FDA UDI
- FDA Product Code
- JOH FDA UDI
- EMDN Code
- R060280 HUMIDIFICATION SYSTEMS - ACCESSORIES EUDAMED
- GMDN Term
- Tracheostoma protective filter FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5800 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Provox BasePlate Adaptor by Atos Medical AB — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 7331791-HME-A-000-0003-F5 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Atos Medical AB
- EUDAMED SRN
- SE-MF-000000725
Sources (2)
- EUDAMED e5dccfec-f544-448c-a677-0b9cedd56089 61 fields · synced Aug 3, 2026
- FDA UDI 694f0ab1-ba4e-4030-92d9-f5e83b041876 37 fields · synced May 30, 2026