Data / Medical devices / Switzerland / Lifescan Europe GMBH
Lifescan Europe GMBH: FDA-registered device maker in CH Zug, Switzerland, 5 510(k) clearances
Lifescan Europe GMBH is registered with the FDA (registration 3008382007) in CH Zug, Switzerland. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated February 14, 2020. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3008382007
- Address
- Dammstrasse 19, CH Zug, Switzerland, 6300
- Owner or operator
- LifeScan Europe, GmbH (10032336)
- Roles
- Specification developer
- First device listed
- April 12, 2011
- Registered through
- 2026
- Brand names listed
- OneTouch Delica Lancing Device and Lancets, OneTouch Delica Plus Lancing Device and Lancets, OneTouch Delica Safety Lancing Device and Lancets, OneTouch FinePoint Lancets, OneTouch Lancing Device, OneTouch Solutions, OneTouch SureSoft Lancet, OneTouch Ultra Plus Control Solution and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Glucose Dehydrogenase, Glucose | LFR | 2 | Specification developer | accessdata.fda.gov |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | 2 | Specification developer | accessdata.fda.gov |
| System, Test, Blood Glucose, Over The Counter | NBW | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 14, 2020 | K193475 | OneTouch Verio Reflect Blood Glucose Monitoring System | NBW | Substantially Equivalent | Lifescan Europe GmbH | accessdata.fda.gov |
| December 14, 2015 | K151611 | OneTouch Ultra Plus Flex Blood Glucose Monitoring System | NBW | Substantially Equivalent | Lifescan Europe | accessdata.fda.gov |
| July 31, 2015 | K150214 | OneTouch Verio Flex Blood Glucose Monitoring System | NBW | Substantially Equivalent | Lifescan Europe | accessdata.fda.gov |
| August 30, 2013 | K131363 | ONETOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | Cilag GmbH International | accessdata.fda.gov |
| September 7, 2011 | K110637 | ONETOUCH VERIO (TM) IQ BLOOD GLUCOSE MONITORING SYSTEM | LFR | Substantially Equivalent | Cilag GmbH International | accessdata.fda.gov |
Compare with other makers
- All makers of Glucose Dehydrogenase, Glucose
- All makers of System, Test, Blood Glucose, Over The Counter
- All makers of Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Updated February 14, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.