Identity
- Trade Name
- Provox HME Cassette Adaptor EUDAMEDFDA UDI
- Generic Name
- Tracheostoma device adaptor, reusable FDA UDI
- Device Name
- Provox HME Cassette Adaptor EUDAMEDProvox HME Cassette Adaptor is intended to facilitate a connection between Provox HME Cassette and on the market available tracheal cannulas with ISO-cone (15 mm). For laryngectomies who need a cannula initially or for a longer period of time. Enables immediate start of pulmonary rehabilitation with HME. FDA UDI
- Model / Reference
- 7246 EUDAMEDFDA UDI
- Description
- Provox HME Cassette Adaptor is intended to facilitate a connection between Provox HME Cassette and on the market available tracheal cannulas with ISO-cone (15 mm). For laryngectomies who need a cannula initially or for a longer period of time. Enables immediate start of pulmonary rehabilitation with HME. FDA UDI
Identifiers
- Catalog Number
- 7246 FDA UDI
- Primary DI / UDI-DI
- 07331791001543 EUDAMEDFDA UDI
- Basic UDI-DI
- 7331791-HME-A-000-0008-FL EUDAMED
- FDA Product Code
- BYD FDA UDI
- EMDN Code
- R060280 HUMIDIFICATION SYSTEMS - ACCESSORIES EUDAMED
- GMDN Term
- Tracheostoma device adaptor, reusable 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 Cassette Adaptor by Atos Medical AB — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Tracheostomy tube speech valve.
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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-000-0008-FL | 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 a79b2a87-b939-469f-b6f2-fd315c1bc621 61 fields · synced Jun 19, 2026
- FDA UDI 78ff2c1a-687a-4c7c-b158-4bbd444ba61e 36 fields · synced May 30, 2026