Iline Microsystems, S.L.

Spain ES-MF-000013573 Last updated 22 Oct 2026

Devices: 25
Registries: EUDAMEDFDA 510(k)FDA
FDA recalls: 0

Catalogue25

microINR Link Kit Ref KTD0001AB

IVD for self-testing EUDAMED Active
microINR Expert Kit Ref KTP0001AA

Class A EUDAMED Active
microINR Chips Ref CHB0025AC

IVD for self-testing EUDAMED Active
microINR kit Ref KTA0001AB

IVD for self-testing EUDAMED Active
microINR kit Ref KTA0001AU

IVD for self-testing EUDAMED Active
microINR Chips Ref CHB0025AA

IVD for self-testing EUDAMED Active
microINR Chips Ref CHB0025AB

IVD for self-testing EUDAMED Active
microINR kit Ref KTA0001PL

IVD for self-testing EUDAMED Active
microINR kit Ref KTA0001AZ

IVD for self-testing EUDAMED Active
microINR kit Ref KTA0001AA

IVD for self-testing EUDAMED Active
microINR Chips Ref CHB0025AU

IVD for self-testing EUDAMED Active
microINR EasyControl Ref EKA0005UU

IVD General EUDAMED Active
microINR Link kit Ref KTE0001AB

IVD for self-testing EUDAMED Active
microINR kit Ref KTB0001AZ

IVD for self-testing EUDAMED Active
microINR Chips Ref CHB0025AB-10

IVD for self-testing EUDAMED Active
microINR kit Ref KTB0001AB

IVD for self-testing EUDAMED Active
microINR kit Ref KTB0001AU

IVD for self-testing EUDAMED Active
microINR Link kit Ref KTE0001AA

IVD for self-testing EUDAMED Active
microINR Link kit Ref KTD0001AA

IVD for self-testing EUDAMED Active
microINR kit Ref KTA0001AC

IVD for self-testing EUDAMED Active
microINR System Ref K243543

Class II FDA 510(k) Active
microINR System Ref K251564

Class II FDA 510(k) Active
microINR System Ref K180780

Class II FDA 510(k) Active
microINR System Ref K231711

Class II FDA 510(k) Active
microINR System Ref K201185

Class II FDA 510(k) Active

FDA establishments1

Registered with the FDA under this company group, matched by name.

Iline Microsystems S.L. Donostia - San Sebastian Guipuzcoa · ES FEI 3010285483

What Iline Microsystems, S.L. makes

Iline Microsystems, S.L. manufactures the microINR System, which is a Class II medical device.

The microINR System is listed in the FDA 510(k) registry, and the company is based in the US.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What medical devices does Iline Microsystems, S.L. manufacture?

Iline Microsystems, S.L. manufactures the microINR System, which is a Class II medical device used for monitoring coagulation levels in patients.

Where is Iline Microsystems, S.L. based?

Iline Microsystems, S.L. is based in the United States, as indicated in the provided device data.

Which regulatory registries list the devices manufactured by Iline Microsystems, S.L.?

The microINR System manufactured by Iline Microsystems, S.L. is listed in the FDA 510(k) registry, which is a premarket notification database for medical devices in the United States.

How are the devices manufactured by Iline Microsystems, S.L. classified?

The microINR System manufactured by Iline Microsystems, S.L. is classified as a Class II medical device, which indicates moderate risk and requires special controls to ensure safety and effectiveness.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: Spain
Address: 69, PASEO MIKELETEGI, Donostia, Spain
Website: ilinemicrosystems.com
Email: [email protected]
PRRC contact: Miren Itsaso Hormaeche Berciano
EUDAMED SRN: ES-MF-000013573

Catalogue25

microINR Link Kit Ref KTD0001AB

microINR Expert Kit Ref KTP0001AA

microINR Chips Ref CHB0025AC

microINR kit Ref KTA0001AB

microINR kit Ref KTA0001AU

microINR Chips Ref CHB0025AA

microINR Chips Ref CHB0025AB

microINR kit Ref KTA0001PL

microINR kit Ref KTA0001AZ

microINR kit Ref KTA0001AA

microINR Chips Ref CHB0025AU

microINR EasyControl Ref EKA0005UU

microINR Link kit Ref KTE0001AB

microINR kit Ref KTB0001AZ

microINR Chips Ref CHB0025AB-10

microINR kit Ref KTB0001AB

microINR kit Ref KTB0001AU

microINR Link kit Ref KTE0001AA

microINR Link kit Ref KTD0001AA

microINR kit Ref KTA0001AC

microINR System Ref K243543

microINR System Ref K251564

microINR System Ref K180780

microINR System Ref K231711

microINR System Ref K201185

FDA establishments1

What Iline Microsystems, S.L. makes

Frequently asked questions

Information