Data / Medical devices / Switzerland / Ypsomed AG
Ypsomed AG: FDA-registered device maker in BURGDORF Bern, Switzerland, 1 510(k) clearance
Ypsomed AG is registered with the FDA (registration 3002806818) in BURGDORF Bern, Switzerland. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 28, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3002806818
- Address
- Brunnmattstrasse 6, BURGDORF Bern, Switzerland, CH-3401
- Owner or operator
- YPSOMED AG (9064115)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- October 18, 2017
- Registered through
- 2026
- Brand names listed
- SmartPilot YpsoMate NS-A2.25
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Injection Data Capture Device | QOG | 2 | Manufacturer | accessdata.fda.gov |
| Injector, Pen | NSC | 2 | Contract manufacturer | accessdata.fda.gov |
| Pump, Infusion, Insulin | LZG | 2 | Contract manufacturer | 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 |
|---|---|---|---|---|---|---|
| August 28, 2025 | K243901 | SmartPilot YpsoMate NS-A2.25 | QOG | Substantially Equivalent | Ypsomed AG | accessdata.fda.gov |
Compare with other makers
- All makers of Injection Data Capture Device
- All makers of Pump, Infusion, Insulin
- All makers of Injector, Pen
Updated August 28, 2025. 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.