Ascensia Diabetes Care Holdings AG
CH-MF-000034124 · Switzerland · Basel
Ascensia Diabetes Care Holdings AG is registered in the European database on medical devices as a manufacturer, with 28 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 22 |
|---|
Most frequent device types declared: LADEV-D-XXXXYY, LAN28-L-XXXXYY.
Among these devices, 10 are declared sterile.
Authorised representative in the Union: Ascensia Diabetes Care Italy Srl.
Devices declared under this manufacturer
- Contour®
- Contour® XT
- Microlet®
- Microlet® Next
Showing 12 of 28 declared devices.
Catalogue references include 81132381, 82224638, 85139894, 85255797, 85255843, 85255908.
European nomenclature codes declared: A99, V010402, W020106019085, W0201060102.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | ASCENSIA DIABETES CARE HOLDINGS AG (CH) · FDA 3012118659 |
| Devices in EUDAMED | 28 |
| Country of registration | Switzerland |
Device-level evidence
| Devices with a numeric GTIN | 22 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | ASCENSIA DIABETES CARE HOLDINGS AG |
What it holds in Canada
| Licences on record | 14 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 6 |
| Class 3 devices | 8 |
| First licensed | 1999-10-08 |
Licence types: Device Family (9), System (2), Device Group (1), Single Device (1).
Licensed under: KETOSTIX, DIASTIX, KETO-DIASTIX, CONTOUR BLOOD GLUCOSE MONITORS, MICROLET - LANCETS, MICROLET COLORED LANCETS.
North American profile: Both markets. Ascensia Diabetes Care Holdings AG is registered in both the United States and Canada.