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Meriscreen HIV 1-2 Wb

by Meril Diagnostics Pvt. Ltd. EUDAMED

Active European Union

Ref HVWRPD-06Model HVWRPD-01 HVWRPD-02 HVWRPD-06 HVWRPD-07 HVWRPD-08 HVWRPD-09 HVWRPD-10 HVWRPD-11 HVWRPD-12

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number8905459MHVWRPDJX Basic UDI-DIDate18 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 2023-IVDR/QS-002/B Amended

    Quality management system EU IVDR

    Notified body
    3EC International a.s. 2265
    Issued
    30 Jun 2026
    Expires
    9 Sep 2028
    Reason
    Mnf data change
  • 2023-IVDR/TD-002/B Amended

    Technical documentation EU IVDR

    Notified body
    3EC International a.s. 2265
    Issued
    30 Jun 2026
    Expires
    9 Sep 2028
    Reason
    Mnf data change

Specification

EUDAMED

Device Name
Meriscreen HIV 1-2 Wb
Model / Reference
HVWRPD-01 HVWRPD-02 HVWRPD-06 HVWRPD-07 HVWRPD-08 HVWRPD-09 HVWRPD-10 HVWRPD-11 HVWRPD-12, HVWRPD-06
Primary DI / UDI-DI
08905459001696
Direct Marketing DI
08905459001696
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
IN-MF-000028158
Authorised representative
Obelis s.a. BE-AR-000000106

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