Identity
- Trade Name
- Provox FreeHands Support Flat 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. The reusable Provox FreeHands Support is available in three different variants; ‘Flat’, ‘Medium’ and ‘Deep’. The three variants, as well as the possibility to adjust the metal ring and plastic parts, enable personal fit. FDA UDI
- Model / Reference
- 8021 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. The reusable Provox FreeHands Support is available in three different variants; ‘Flat’, ‘Medium’ and ‘Deep’. The three variants, as well as the possibility to adjust the metal ring and plastic parts, enable personal fit. FDA UDI
Identifiers
- Catalog Number
- 8021 FDA UDI
- Primary DI / UDI-DI
- 07331791009273 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
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 Flat 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
- nonventilatory nebulizer(atomizer)(JR-CA007-03) — Xiamen Junrong Medical Equipment Co., Ltd. · Class I
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Atos Medical AB
- EUDAMED SRN
- SE-MF-000000725
Sources (2)
- EUDAMED 35cc5c14-af24-4bcd-b396-4ef854da55bb 61 fields · synced Jul 29, 2026
- FDA UDI cbb9b2fd-45c9-4cc4-b73f-5e7acb532d71 36 fields · synced May 30, 2026