Data / Medical devices / Switzerland / CeQur SA
CeQur SA: FDA-registered device maker in Horw Luzern, Switzerland, 1 510(k) clearance
CeQur SA is registered with the FDA (registration 3015218509) in Horw Luzern, Switzerland. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 7, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015218509
- Address
- Ebenaustrasse 10, Horw Luzern, Switzerland, 6048
- Owner or operator
- CeQur Corporation (10046968)
- Roles
- Specification developer
- First device listed
- February 4, 2019
- Registered through
- 2026
- Brand names listed
- CeQur Simplicity Patch
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Pump, Infusion, Insulin | LZG | 2 | Specification developer | accessdata.fda.gov |
| Pump, Infusion, Insulin Bolus | OPP | 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 |
|---|---|---|---|---|---|---|
| June 7, 2017 | K163357 | OneTouch Via On-Demand Insulin Delivery System | OPP | Substantially Equivalent | Lifescan Europe, A Division of Cilag GmbH | accessdata.fda.gov |
Compare with other makers
Updated June 7, 2017. 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.