Identity
- Trade Name
- Provox Luna Set EUDAMEDFDA UDI
- Generic Name
- Tracheostoma protective filter FDA UDI
- Device Name
- Provox Luna Set EUDAMEDThe Provox Luna Set is a combination of Provox Luna HME and Provox Luna Adhesive. Provox Luna HME: The Provox Luna HME is a single use heat- and moisture exchanger, attachable to the Provox Luna Adhesive, for night-time use after total laryngectomy. Provox Luna Adhesive: The Provox Luna Adhesive is a skin friendly, single use adhesive that provides attachment for the Provox Luna HME for night time use after total laryngectomy. FDA UDI
- Model / Reference
- 8025 EUDAMEDFDA UDI
- Description
- The Provox Luna Set is a combination of Provox Luna HME and Provox Luna Adhesive. Provox Luna HME: The Provox Luna HME is a single use heat- and moisture exchanger, attachable to the Provox Luna Adhesive, for night-time use after total laryngectomy. Provox Luna Adhesive: The Provox Luna Adhesive is a skin friendly, single use adhesive that provides attachment for the Provox Luna HME for night time use after total laryngectomy. FDA UDI
Identifiers
- Catalog Number
- 8025 FDA UDI
- Primary DI / UDI-DI
- 07331791010699 EUDAMEDFDA UDI
- Basic UDI-DI
- 7331791-KIT-0-000-0002-HS 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
- Denmark 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
Yes
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 Luna Set 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-KIT-0-000-0002-HS | 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 0766ddfb-9c1d-4030-8a71-613cde2713d2 61 fields · synced Jun 20, 2026
- FDA UDI 1f68cafe-086c-4ba0-be67-5aa4f0bf0d28 36 fields · synced May 30, 2026