Identity
- Trade Name
- Provox Adhesive Remover (50 pcs) EUDAMEDFDA UDI
- Generic Name
- Patient medical adhesive remover FDA UDI
- Device Name
- Provox Adhesive Remover EUDAMEDProvox Adhesive Remover is a single use wipe to help laryngectomized patients remove Provox Adhesives and Provox Silicone Glue. FDA UDI
- Model / Reference
- 8012 EUDAMEDFDA UDI
- Description
- Provox Adhesive Remover is a single use wipe to help laryngectomized patients remove Provox Adhesives and Provox Silicone Glue. FDA UDI
Identifiers
- Catalog Number
- 8012 FDA UDI
- Primary DI / UDI-DI
- 07331791009235 EUDAMEDFDA UDI
- Basic UDI-DI
- 7331791-ADH-A-000-0005-UP EUDAMED
- Unit of Use DI
- 07331791016370 EUDAMED
- FDA Product Code
- KOX FDA UDI
- EMDN Code
- M9003 SOLUTIONS FOR ADHESIVE TAPE REMOVAL EUDAMED
- GMDN Term
- Patient medical adhesive remover FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4730 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
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: Patient medical adhesive remover
Provox Adhesive Remover (50 pcs) by Atos Medical Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Patient medical adhesive remover.
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- Adapt — Hollister Incorporated · Class I
- DETACHOL — Ferndale Laboratories, Inc. · Class I
- BodyMed — BOXOUT, LLC · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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 44b2fab2-c908-4006-8e4e-f008b1f01921 36 fields · synced Jun 20, 2026
- EUDAMED 61106f87-8858-4e57-8319-0fa49e867a25 61 fields · synced Jun 20, 2026