Data / Medical devices / Switzerland / Cordiana Medical Informatics AG
Cordiana Medical Informatics AG: FDA-registered device maker in Root D4 Luzern, Switzerland, 1 510(k) clearance
Cordiana Medical Informatics AG is registered with the FDA (registration 3022780114) in Root D4 Luzern, Switzerland. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated November 16, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3022780114
- Address
- Platz 4, Root D4 Luzern, Switzerland, 6039
- Owner or operator
- Cordiana Medical Informatics AG (10085146)
- Roles
- Manufacturer
- First device listed
- May 11, 2022
- Registered through
- 2026
- Brand names listed
- Cordiana Dx16
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Computer, Diagnostic, Programmable | DQK | 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 |
|---|---|---|---|---|---|---|
| November 16, 2020 | K201060 | Cordiana Dx16 | DQK | Substantially Equivalent | Cordiana Medical Informatics AG | accessdata.fda.gov |
Compare with other makers
Updated November 16, 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.