Data / Medical devices / Switzerland / Comerge AG
Comerge AG: FDA-registered device maker in Zurich, Switzerland, 2 510(k) clearances
Comerge AG is registered with the FDA (registration 3025343017) in Zurich, Switzerland. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 20, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3025343017
- Address
- Bubenbergstrasse 1, Zurich, Switzerland, 8045
- Owner or operator
- Comerge AG (10086348)
- Roles
- Manufacturer
- First device listed
- May 13, 2024
- Registered through
- 2026
- Brand names listed
- Neo ADVISE software, T1D1
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Calculator, Drug Dose | NDC | 2 | Manufacturer | accessdata.fda.gov |
| Orthopedic Stereotaxic Instrument | OLO | 2 | 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 20, 2025 | K252104 | T1D1 | NDC | Substantially Equivalent | Comerge AG | accessdata.fda.gov |
| March 8, 2024 | K230195 | Neo ADVISE software | OLO | Substantially Equivalent | Comerge AG | accessdata.fda.gov |
Compare with other makers
Updated August 20, 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.