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Provox FreeHands Support Adhesive (15 pcs)
EUDAMEDFDA UDIClass I (EU MDR)
Ref 8024
Identity
- Trade Name
- Provox FreeHands Support Adhesive (15 pcs) EUDAMEDFDA UDI
- Generic Name
- Removable ambulatory appliance skin-adherent patch FDA UDI
- Device Name
- Provox FreeHands Support Adhesive EUDAMEDThe Provox FreeHands Support system consists of two parts; Provox FreeHands Support and Provox FreeHands Support Adhesive. Provox FreeHands Support Adhesive is a single-use adhesive that is attached to the skin, beneath the Provox Adhesive. FDA UDI
- Model / Reference
- 8024 EUDAMEDFDA UDI
- Description
- The Provox FreeHands Support system consists of two parts; Provox FreeHands Support and Provox FreeHands Support Adhesive. Provox FreeHands Support Adhesive is a single-use adhesive that is attached to the skin, beneath the Provox Adhesive. FDA UDI
Identifiers
- Catalog Number
- 8024 FDA UDI
- Primary DI / UDI-DI
- 07331791009303 EUDAMEDFDA UDI
- Basic UDI-DI
- 7331791-HME-A-000-0004-F8 EUDAMED
- Unit of Use DI
- 07331791016516 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
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: Tracheostomy tube speech valve
Provox FreeHands Support Adhesive (15 pcs) by Atos Medical AB — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Tracheostomy tube speech valve.
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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-HME-A-000-0004-F8 | 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 09a01003-29fa-42e2-a644-8fd8171626ed 61 fields · synced Jun 17, 2026
- FDA UDI 5202fbaa-0c17-4ac6-b147-8a5f88eab43f 36 fields · synced May 30, 2026