- Role
- Country
- Date of registration
- Address
SE-MF-000000725Provox SolaTone Plus is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Atos Medical AB. Placed on the EU market in Austria. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on May 27, 2026
7331791-ELX-0-A00-0001-VJPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)07331791015823
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
Primary placement in Austria; available across 19 countries total.
| Country | On market since | Until |
|---|---|---|
| AustriaPrimary placement | — | Still on market |
| Bulgaria | — | Still on market |
| Cyprus | — | Still on market |
| EL | — | Still on market |
| France | — | Still on market |
| Croatia | — | Still on market |
| Hungary | — | Still on market |
| Ireland | — | Still on market |
| Iceland | — | Still on market |
| Italy | — | Still on market |
| Lithuania | — | Still on market |
| Latvia | — | Still on market |
| Malta | — | Still on market |
| Netherlands | — | Still on market |
| Poland | — | Still on market |
| Romania | — | Still on market |
| Slovakia | — | Still on market |
| Türkiye | — | Still on market |
| XI | — | Still on market |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
07331791015823Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
7331791-ELX-0-A00-0001-VJ7438UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
MDR risk classes
MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.
European Medical Device Nomenclature — the EU product classification assigned to this device.
Y214212VOICE GENERATORSCertificate health across this manufacturer's portfolio.
C520850IssuedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →No certificate specifically references this device's Basic UDI-DI.
7331791-ADH-A-000-0000-U8On the marketProvox Silicone Glue7331791-GEN-A-000-0003-EFOn the marketProvox Skin Barrier (50 pcs)7331791-ADH-A-000-0004-ULOn the marketProvox StabiliBase (15 pcs)7331791-ADH-0-000-0000-CQOn the marketProvox StabiliBase OptiDerm (15 pcs)7331791-ADH-0-000-0000-CQOn the marketProvox Swab Large7331791-GEN-A-000-0002-ECOn the market