Identity
- Trade Name
- Provox HME Cap EUDAMEDFDA UDI
- Generic Name
- Tracheostoma protective filter FDA UDI
- Device Name
- Provox HME Cap EUDAMEDProvox HME Cap is a dome-shaped titanium ring for rehabilitation after total laryngectomy. It allows use of the Provox FreeHands HME Cassettes without the Provox FreeHands HME Speech Valve. The front opening of the cap can be occluded manually to speak. FDA UDI
- Model / Reference
- 7730 EUDAMEDFDA UDI
- Description
- Provox HME Cap is a dome-shaped titanium ring for rehabilitation after total laryngectomy. It allows use of the Provox FreeHands HME Cassettes without the Provox FreeHands HME Speech Valve. The front opening of the cap can be occluded manually to speak. FDA UDI
Identifiers
- Catalog Number
- 7730 FDA UDI
- Primary DI / UDI-DI
- 07331791003011 EUDAMEDFDA UDI
- Basic UDI-DI
- 7331791-HME-A-000-0002-F2 EUDAMED
- FDA Product Code
- BYD FDA UDI
- EMDN Code
- R060280 HUMIDIFICATION SYSTEMS - ACCESSORIES EUDAMED
- GMDN Term
- Tracheostoma protective filter FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.5375 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Tracheostomy tube speech valve
Provox HME Cap by Atos Medical AB — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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-000-0002-F2 | 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 dc8f5b12-ad38-4acb-bf43-0c752ea47d85 61 fields · synced Jul 12, 2026
- FDA UDI d47592d2-b0d7-4a55-9b4c-3e6d91a6d360 36 fields · synced May 30, 2026