inforMED
FEI 3007697975

Euromi S.a.

Rue des Nouvelles Technologies, 11, Andrimont Liege, BE

MDR events0All time
Recalls0All time
Registered products2
Establishment typeManufactureManufacture Medical Device

Registered product codes

2 product codes

Recent MDR events

0 on file

No MDR events on file for this firm name.

Recalls

0 on file

No recalls on file for this firm name.

Compliance history

Matched by FEI 3007697975.

FDA inspections

2 on file

  • Voluntary Action Indicated (VAI)Jul 31, 2025

    Compliance: Devices · Citations posted

  • Voluntary Action Indicated (VAI)Jul 31, 2025

    Postmarket Assurance: Devices · Citations posted

Inspection citations

5 on file

  • 21 CFR 803.18(a)Jul 31, 2025

    Event files -- failure to establish and maintain

  • 21 CFR 820.70(a)Jul 31, 2025

    Process control procedures, Lack of or inadequate procedures

  • 21 CFR 820.80(a)Jul 31, 2025

    Lack of or inadequate procedures - Acceptance activities

  • 21 CFR 820.100(a)Jul 31, 2025

    Lack of or inadequate procedures

  • 21 CFR 830.300(a)Jul 31, 2025

    Devices subject to device identification GUDID data submission requirements.

Compliance actions

0 on file

No warning letters or injunctions on file for this FEI number.

Import refusals

0 on file

No import refusals on file for this FEI number.