Data / Medical devices / Spain / Iline Microsystems S.L.
Iline Microsystems S.L.: FDA-registered device maker in Donostia - San Sebastian Guipuzcoa, Spain, 3 510(k) clearances
Iline Microsystems S.L. is registered with the FDA (registration 3010285483) in Donostia - San Sebastian Guipuzcoa, Spain. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated July 21, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010285483
- Address
- Paseo Mikeletegi, 69, Donostia - San Sebastian Guipuzcoa, Spain, 20009
- Owner or operator
- iLine Microsystems S.L. (10081748)
- Roles
- Manufacturer
- First device listed
- May 27, 2021
- Registered through
- 2026
- Brand names listed
- microINR Chips, microINR Expert Kit, microINR Kit, microINR Link Kit, microINR Link kit
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Test, Time, Prothrombin | GJS | 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 |
|---|---|---|---|---|---|---|
| July 21, 2025 | K251564 | microINR System | GJS | Substantially Equivalent | Iline Microsystems, S.L. | accessdata.fda.gov |
| July 11, 2023 | K231711 | microINR System | GJS | Substantially Equivalent | Iline Microsystems, S.L. | accessdata.fda.gov |
| December 18, 2020 | K201185 | microINR System | GJS | Substantially Equivalent | Iline Microsystems, S.L. | accessdata.fda.gov |
Compare with other makers
Updated July 21, 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.