AristoDent AB
SE-MF-000055120 · Sweden · Flen
AristoDent AB is registered in the European database on medical devices as a manufacturer, with 40 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 40 |
|---|
Most frequent device types declared: BORRIX, BORRIXDISK.
Among these devices, 8 are declared active.
Devices declared under this manufacturer
- BORRIX MINI Dish 4 Black
- BORRIX MINI Dish 6 Black
- BORRIX MINI Gray
- BORRIX MINI Green
- BORRIX MINI NeonGreen
- BORRIX MINI NeonYellow
- BORRIX MINI Red
- BORRIX MINI Turquose
- BORRIX Original Blue
- BORRIX Original Dish 6 White
- BORRIX Original Light Blue
- BORRIX Original Orange
Showing 12 of 40 declared devices.
Catalogue references include 30513, 30515, 30614, 3070811, 3070813, 30720.
European nomenclature codes declared: L159099.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 40 |
| Country of registration | Sweden |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 40 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. AristoDent AB was not found in either the U.S. or the Canadian register.