Atos Medical AB
SE-MF-000000725 · Sweden · Hörby
Atos Medical AB is registered in the European database on medical devices as a manufacturer, with 181 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 181 |
|---|
Among these devices, 3 are declared active.
Devices declared under this manufacturer
- Clothing round T-shirt w zip lock white
- Freevent Dressing Combi 90x150
- Freevent Dressing Dbl AL slt 90x150
- Provox Adhesive OptiDerm Oval
- Provox Brush Long XL
- Provox Life Night HME
- Provox Luna Set
- Provox Protector Slim Large White
- Provox Skin Barrier (50 pcs)
- Provox Tracheofix 1 strip beige 55x60
- Provox TruTone Plus
- Provox XtraBase Adhesive
Showing 12 of 181 declared devices.
Catalogue references include 1413RSR1, 14259, 1429H, 7256, 7265, 7290.
European nomenclature codes declared: R060299, R060280, R9099, M0499, Q0399, R01058099.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | ATOS MEDICAL AB (SE) · FDA 8032044 |
| Devices in EUDAMED | 181 |
| Country of registration | Sweden |
Device-level evidence
| Devices with a numeric GTIN | 181 |
|---|---|
| Found in the U.S. device database | 122 |
| Share | 67.4 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | ATOS MEDICAL AB |
What it holds in Canada
| Licences on record | 23 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 17 |
| Class 3 devices | 6 |
| First licensed | 2005-01-05 |
Licence types: Device Family (8), Single Device (8), System (5), Device Group Family (2).
Licensed under: THE PROVOX HME SYSTEM, THE PROVOX VOICE PROSTHESIS ACCESSORIES SYSTEM, THE PROVOX FREEHANDS HME SYSTEM, THE PROVOX NID VOICE PROSTHESIS SYSTEM, THE PROVOX2 VOICE PROSTHESIS SYSTEM, THE ACTIVALVE SYSTEM.
North American profile: Both markets. Atos Medical AB is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
C520850 | issued | 2030-02-11 |