Data / Medical devices / Germany / Numares AG
Numares AG: FDA-registered device maker in Regensburg Bavaria, Germany, 1 510(k) clearance
Numares AG is registered with the FDA (registration 3011080315) in Regensburg Bavaria, Germany. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated July 19, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011080315
- Address
- Am BioPark 13, Regensburg Bavaria, Germany, 93053
- Owner or operator
- Numares AG (10088504)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- August 4, 2023
- Registered through
- 2026
- Brand names listed
- AXINON® LDL-p Test System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Test, Low Density, Lipoprotein | MRR | 1 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| July 19, 2023 | K210801 | AXINON® LDL-p Test System | MRR | Substantially Equivalent | Numares AG | accessdata.fda.gov |
Compare with other makers
Updated July 19, 2023. 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.