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Thermodiag

by F2D Medical EUDAMED

Active European Union

Ref TH01-Kt01-Eu

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number376039807TH001AH Basic UDI-DIDate17 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • EPT 0477.MDR.26/6094 Issued

    Quality management system EU MDR

    Notified body
    Notified body 0477
    Issued
    13 Mar 2026
    Expires
    12 Mar 2031

Specification

EUDAMED

Model / Reference
TH01-Kt01-Eu
Primary DI / UDI-DI
03760398070043
Basic UDI-DI
376039807TH001AH
EMDN Code
V030199 Body temperature measuring devices - other
Device Class
Class IIb
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000035850

Other devices from F2D Medical

Properties

  • Measuring Function

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No