Identity
- Trade Name
- Provox Adhesive OptiDerm Round EUDAMEDFDA UDI
- Generic Name
- Removable ambulatory appliance skin-adherent patch FDA UDI
- Device Name
- Provox Adhesive EUDAMEDThe Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices are attached to the skin around the tracheostoma in order to provide attachment for components of the Provox HME System. FDA UDI
- Model / Reference
- 7255 EUDAMEDFDA UDI
- Description
- The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices are attached to the skin around the tracheostoma in order to provide attachment for components of the Provox HME System. FDA UDI
Identifiers
- Catalog Number
- 7255 FDA UDI
- Primary DI / UDI-DI
- 07331791001635 EUDAMEDFDA UDI
- Basic UDI-DI
- 7331791-ADH-0-000-0000-CQ EUDAMED
- Unit of Use DI
- 07331791016905 EUDAMED
- FDA Product Code
- KGX FDA UDI
- EMDN Code
- R060280 HUMIDIFICATION SYSTEMS - ACCESSORIES EUDAMED
- GMDN Term
- Removable ambulatory appliance skin-adherent patch FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.5240 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
Yes
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Removable ambulatory appliance skin-adherent patch
Provox Adhesive OptiDerm Round by Atos Medical Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Atos Medical Inc.
Sources (2)
- FDA UDI e198274f-0a22-4a36-8820-ff22c1c31a6e 36 fields · synced Jul 27, 2026
- EUDAMED 44ce7108-0408-4c62-b6b6-e7e6d178a333 61 fields · synced Jul 27, 2026