LifeScan Europe GmbH
CH-MF-000014224 · Switzerland · Zug
LifeScan Europe GmbH is registered in the European database on medical devices as a manufacturer, with 88 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Most frequent device types declared: 022179, 022222, 022224, 022894, 023764.
Authorised representative in the Union: LifeScan Deutschland GmbH.
Devices declared under this manufacturer
- OneTouch Reveal Web Application
- OneTouch Select Plus Control Solution
- OneTouch Select Plus Flex
- OneTouch Select Plus test strip
- OneTouch SelectPlus
- OneTouch SelectPlus Flex
- OneTouch Ultra Plus Control Solution
- OneTouch Ultra Plus Reflect
- OneTouch Ultra Plus test strip
- OneTouch Verio Control Solution
- OneTouch Verio Flex
- OneTouch Verio Reflect
Showing 12 of 88 declared devices.
Catalogue references include 022222, 022224, 022894, 023775, 023847, 024146.
European nomenclature codes declared: W0101060101, W0201060102, W0101050205, W020106019092.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | LIFESCAN EUROPE GMBH (CH) · FDA 3008382007 |
| Devices in EUDAMED | 88 |
| Country of registration | Switzerland |
Device-level evidence
| Devices with a numeric GTIN | 88 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | LIFESCAN EUROPE GMBH |
What it holds in Canada
| Licences on record | 8 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 1 |
| Class 3 devices | 7 |
| First licensed | 2000-11-28 |
Licence types: Device Family (6), System (2).
Licensed under: ONETOUCH BLOOD GLUCOSE METERS, ONETOUCH GLUCOSE TEST STRIPS, ONETOUCH GLUCOSE CONTROLS, ONETOUCH VERIO GLUCOSE TEST STRIPS, ONETOUCH VERIO GLUCOSE CONTROL, ONETOUCH VERIO FLEX BLOOD GLUCOSE MONITORING S.
North American profile: Both markets. LifeScan Europe GmbH is registered in both the United States and Canada.