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CoaguChek INRange

by Roche Diagnostics GmbH 8 variants

Ref 07404379019

CoaguChek INRange (07404379019) is a Class C device made by Roche Diagnostics GmbH, registered in EUDAMED on 10 Sep 2026 (Basic UDI-DI 761333601490AT), active as of 7 Nov 2026.

Active European Union

CE IVDR

Valid until

23 Sep 2031

CE IVDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier TÜV SÜD Product Service GmbH

Trust

Unverified

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number761333601490AT Basic UDI-DI 00064562212592UDI-DIDate10 Sep 2026RegisteredStatusActive

Official records

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • V76 010283 0743 Active Reissued

    Technical documentation EU IVDR

    Certifier
    TÜV SÜD Product Service GmbH 0123
    Issued
    8 Sep 2026
    Expires
    23 Sep 2031
    Valid from
    24 Sep 2026

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Model / reference
07404379019
Primary DI / UDI-DI
00064562212592
Basic UDI-DI
761333601490AT
EMDN code
W02020602 Rapid test hemostasis instruments
Device class
Class C
EU registration type
Standard device
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000006260

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Properties

  • Self-testing
  • IVD instrument
Other properties (11, all answered No)