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Elecsys HTLV-I/II

by Roche Diagnostics GmbH EUDAMED

Active European Union

Ref 09730826190

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number761333603075AR Basic UDI-DIDate24 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • V70 010283 0676 Supplemented

    Technical documentation EU IVDR

    Notified body
    TÜV SÜD Product Service GmbH 0123
    Issued
    31 Jul 2026
    Expires
    23 Jan 2029
    Reason
    Add device or group

Specification

EUDAMED

Device Name
Elecsys HTLV
Model / Reference
09730826190
Primary DI / UDI-DI
07613336217108
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000006260

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