Identity
- Trade Name
- Provox Micron HME (5 pcs) EUDAMEDFDA UDI
- Generic Name
- Tracheostoma protective filter FDA UDI
- Device Name
- Provox Micron HME EUDAMEDProvox Micron HME is a disposable device that features a calcium chloride-treated foam core in a plastic housing. Provox Micron HME also contains an electrostatic filter material which reduces airborne particles. The filter consists of synthetic fibres which, during the manufacturing process, generate electrical charges on the fibre surface. The result is a highly stable, coarse fibred electrostatic filter media with high efficiency against sub-micron particles and low air flow resistance.The housing of Provox Micron HME can be pressed down to occlude the stoma in order to speak with a voice prosthesis. When the pressure is released, the housing automatically retracts and opens the airway passage. FDA UDI
- Model / Reference
- 7247 EUDAMEDFDA UDI
- Description
- Provox Micron HME is a disposable device that features a calcium chloride-treated foam core in a plastic housing. Provox Micron HME also contains an electrostatic filter material which reduces airborne particles. The filter consists of synthetic fibres which, during the manufacturing process, generate electrical charges on the fibre surface. The result is a highly stable, coarse fibred electrostatic filter media with high efficiency against sub-micron particles and low air flow resistance.The housing of Provox Micron HME can be pressed down to occlude the stoma in order to speak with a voice prosthesis. When the pressure is released, the housing automatically retracts and opens the airway passage. FDA UDI
Identifiers
- Catalog Number
- 7247 FDA UDI
- Primary DI / UDI-DI
- 07331791001550 EUDAMEDFDA UDI
- Basic UDI-DI
- 7331791-HME-0-000-0002-XF EUDAMED
- Unit of Use DI
- 07331791010590 EUDAMED
- 510(k) Number
- K072582 FDA UDI
- FDA Product Code
- JOH FDA UDI
- EMDN Code
- R060299 HUMIDIFICATION SYSTEMS - OTHER 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
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
Yes
FDA UDI
Over-the-Counter
No
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 Micron HME (5 pcs) by Atos Medical AB — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K072582 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 7331791-HME-0-000-0002-XF | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Atos Medical AB
- EUDAMED SRN
- SE-MF-000000725
Sources (3)
- EUDAMED 5ad3d53e-f2bc-4b0a-a6d2-aef638ab731b 61 fields · synced Jun 19, 2026
- FDA UDI ebbcecd4-c29c-41af-b37f-1ef58f268745 37 fields · synced May 30, 2026
- FDA 510(k) K072582 1 fields · synced May 18, 2026