Identity
- Trade Name
- Provox FreeHands Support Starter Set EUDAMEDFDA UDI
- Generic Name
- Tracheostomy base plate, reusable FDA UDI
- Device Name
- Provox FreeHands Support EUDAMEDProvox FreeHands Support provides support to the Provox adhesive when using a Provox hands-free speaking valve after total laryngectomy. The device is a single patient use device with a single use adhesive. FDA UDI
- Model / Reference
- 8020 EUDAMEDFDA UDI
- Description
- Provox FreeHands Support provides support to the Provox adhesive when using a Provox hands-free speaking valve after total laryngectomy. The device is a single patient use device with a single use adhesive. FDA UDI
Identifiers
- Catalog Number
- 8020 FDA UDI
- Primary DI / UDI-DI
- 07331791009266 EUDAMEDFDA UDI
- Basic UDI-DI
- 7331791-HME-A-000-0000-EU EUDAMED
- FDA Product Code
- CBH FDA UDI
- EMDN Code
- R060280 HUMIDIFICATION SYSTEMS - ACCESSORIES EUDAMED
- GMDN Term
- Tracheostomy base plate, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.5770 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
Yes
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 Starter Set by Atos Medical AB — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tracheostomy tube speech valve.
- Nonventilatory nebulizer(atomizer)(JR-CA007-02) — Xiamen Junrong Medical Equipment Co., Ltd. · Class I
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- InHealth Technologies; Blom-Singer® — FREUDENBERG MEDICAL, LLC · Class II
- Montgomery® Tracheostomy Speaking Valve — Boston Medical Products, Inc. · Class II
- Connector — VADI Medical Technology Co., Ltd. · Class IIb
- Humidification Chamber, Infant — BESMED HEALTH BUSINESS CORP. · Class IIa
- Patient Interfaces（Nasal Cannula） — Shenzhen Lifotronic Technology Co., Ltd. · Class IIa
- Provox FreeHands FlexiVoice Set Plus — ATOS MEDICAL INC. · Class II
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-000-0000-EU | 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 940359bc-9e51-4811-9145-66e6f22d7de2 61 fields · synced Jun 19, 2026
- FDA UDI 113b1f5f-c2a4-4a09-b691-0c58abf7b26b 36 fields · synced May 30, 2026