Identity
- Trade Name
- Provox OptiDerm Oval (3 pcs) 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 of components of the Provox HME System. FDA UDI
- Model / Reference
- 8237 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 of components of the Provox HME System. FDA UDI
Identifiers
- Catalog Number
- 8237 FDA UDI
- Primary DI / UDI-DI
- 07331791010330 EUDAMEDFDA UDI
- Basic UDI-DI
- 7331791-ADH-0-000-0000-CQ EUDAMED
- Unit of Use DI
- 07331791017186 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
- Iceland 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 OptiDerm Oval (3 pcs) by Atos Medical Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Removable ambulatory appliance skin-adherent patch.
- InHealth Technologies; Blom-Singer — FREUDENBERG MEDICAL, LLC · Class I
- InHealth Technologies; Blom-Singer — FREUDENBERG MEDICAL, LLC · Class I
- InHealth Technologies; Blom-Singer — FREUDENBERG MEDICAL, LLC · Class I
- Vitus — H R Pharmaceuticals, Inc. · Class I
- InHealth Technologies; Blom-Singer — FREUDENBERG MEDICAL, LLC · Class I
- AURA — Branchpoint & Aura Development LLC · Class II
- Curaplex — TRI-ANIM HEALTH SERVICES, INC. · Class I
- InHealth Technologies; Blom-Singer — FREUDENBERG MEDICAL, LLC · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Atos Medical Inc.
Sources (2)
- FDA UDI 013959d2-5938-4bc0-9a7e-af03a5c7d6b2 36 fields · synced Jul 30, 2026
- EUDAMED 85041ff7-d86a-4700-9a45-4f83cc2b7b76 61 fields · synced Jul 30, 2026