Abbott Diabetes Care Ltd
GB-MF-000029309 · United Kingdom · Witney
Abbott Diabetes Care Ltd is registered in the European database on medical devices as a manufacturer, with 91 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 90 |
|---|---|
| Class IIa | 1 |
Among these devices, 26 are declared sterile, 91 active, 90 with a measuring function.
Authorised representative in the Union: Abbott B.V..
Devices declared under this manufacturer
- FreeStyle LIbre 3 Continuous Glucose Monitoring System
- FreeStyle Libre 2 Flash Glucose Monitoring System
- FreeStyle Libre 2 Flash Glucose Monitoring System
- FreeStyle Libre 2 Plus Flash Glucose Monitoring System
- FreeStyle Libre 3 Continuous Glucose Monitoring System
- FreeStyle Libre 3 Plus Continuous Glucose Monitoring System
- FreeStyle Libre 3 app
- FreeStyle LibreLink app
- Instinct Glucose Sensor
- Instinct Go Glucose Sensor
- Libre
- LibreView
Showing 12 of 91 declared devices.
Catalogue references include 71889-01, 72225-01, 72231-01, 72233-01, 78795-02, 78958-01.
European nomenclature codes declared: Z1204011501, Z1204011585.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | ABBOTT DIABETES CARE LIMITED (GB) · FDA 9710492 |
| Devices in EUDAMED | 91 |
| Country of registration | United Kingdom |
Device-level evidence
| Devices with a numeric GTIN | 91 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | ABBOTT DIABETES CARE INC. |
What it holds in Canada
| Licences on record | 1 |
|---|---|
| Currently active | 0 |
| Class 3 devices | 1 |
| First licensed | 2004-04-05 |
Licence types: Single Device (1).
Licensed under: FREESTYLE CONTROL SOLUTIONS.
North American profile: Both markets. Abbott Diabetes Care Ltd is registered in both the United States and Canada.