Identity
- Trade Name
- Provox Life FreeHands HME EUDAMEDFDA UDI
- Generic Name
- Tracheostoma protective filter FDA UDI
- Device Name
- Provox Life FreeHands HME EUDAMEDProvox Life FreeHands HME is a single use heat- and moisture exchanger intended for spontaneously breathing laryngectomized patients, utilizing a voice prosthesis and in combination with a Provox speaking valve. FDA UDI
- Model / Reference
- 7440 EUDAMEDFDA UDI
- Description
- Provox Life FreeHands HME is a single use heat- and moisture exchanger intended for spontaneously breathing laryngectomized patients, utilizing a voice prosthesis and in combination with a Provox speaking valve. FDA UDI
Identifiers
- Catalog Number
- 7440 FDA UDI
- Primary DI / UDI-DI
- 07331791014895 EUDAMEDFDA UDI
- Basic UDI-DI
- 7331791-HME-0-000-0008-XZ EUDAMED
- Unit of Use DI
- 07331791016769 EUDAMED
- FDA Product Code
- BYD FDA UDI
- EMDN Code
- R060299 HUMIDIFICATION SYSTEMS - OTHER 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
Yes
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
Provox Life FreeHands HME 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-0-000-0008-XZ | 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 77294f41-558c-4064-bc1e-ef4309ca7155 61 fields · synced Jun 19, 2026
- FDA UDI 65e821c7-955a-4861-b6b8-1fd35dcefec2 36 fields · synced May 29, 2026