Identity
- Trade Name
- Provox TruTone Plus EUDAMEDFDA UDI
- Generic Name
- Transcervical artificial larynx FDA UDI
- Device Name
- Provox SolaTone, Provox TruTone EUDAMEDAn electrolarynx is a battery-powered artificial larynx that is externally applied on undamaged skin and intended for use in the absence of the larynx or the inability to use the larynx to produce sound. FDA UDI
- Model / Reference
- 7444 EUDAMEDFDA UDI
- Description
- An electrolarynx is a battery-powered artificial larynx that is externally applied on undamaged skin and intended for use in the absence of the larynx or the inability to use the larynx to produce sound. FDA UDI
Identifiers
- Catalog Number
- 7444 FDA UDI
- Primary DI / UDI-DI
- 07331791015571 EUDAMEDFDA UDI
- Basic UDI-DI
- 7331791-ELX-0-A00-0001-VJ EUDAMED
- FDA Product Code
- ESE FDA UDI
- EMDN Code
- Y214212 VOICE GENERATORS EUDAMED
- GMDN Term
- Transcervical artificial larynx FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 874.3375 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Transcervical artificial larynx
Provox TruTone Plus by Atos Medical Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Transcervical artificial larynx.
- SolaTone® Electrolarynx — GRIFFIN LABORATORIES · Class I
- SolaTone Plus™ Electrolarynx — GRIFFIN LABORATORIES · Class I
- Liberty® Electrolarynx — GRIFFIN LABORATORIES · Class I
- SolaTone Plus™ Electrolarynx — GRIFFIN LABORATORIES · Class I
- TruTone EMOTE® Electrolarynx — GRIFFIN LABORATORIES · Class I
- SolaTone Plus™ Electrolarynx — GRIFFIN LABORATORIES · Class I
- TruTone Plus® Electrolarynx — GRIFFIN LABORATORIES · Class I
- TruTone® Electrolarynx — GRIFFIN LABORATORIES · 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 42a96734-66b7-43d0-9536-eb077343cd86 36 fields · synced Jun 20, 2026
- EUDAMED f19330d5-09a6-4b8c-8f07-a8b85ff77a54 61 fields · synced Jun 20, 2026