Identity
- Trade Name
- Provox Luna ShowerAid EUDAMEDFDA UDI
- Generic Name
- Tracheostoma shower shield FDA UDI
- Device Name
- Provox Luna ShowerAid EUDAMEDProvox Luna ShowerAid is single patient use device intended to be placed into a Provox Luna Adhesive while taking a shower to protect the tracheostoma from water. FDA UDI
- Model / Reference
- 8016 EUDAMEDFDA UDI
- Description
- Provox Luna ShowerAid is single patient use device intended to be placed into a Provox Luna Adhesive while taking a shower to protect the tracheostoma from water. FDA UDI
Identifiers
- Catalog Number
- 8016 FDA UDI
- Primary DI / UDI-DI
- 07331791009532 EUDAMEDFDA UDI
- Basic UDI-DI
- 7331791-ADH-A-000-0007-UV EUDAMED
- FDA Product Code
- BYD FDA UDI
- EMDN Code
- R9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER EUDAMED
- GMDN Term
- Tracheostoma shower shield 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: Pulmonary function analysis system, adult
Provox Luna ShowerAid 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-ADH-A-000-0007-UV | 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 0c80d7cc-c73b-44ce-8473-947f5fe19403 61 fields · synced Jul 13, 2026
- FDA UDI 7e82e627-ad64-497e-a443-b1dc43660de5 36 fields · synced May 29, 2026