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UniPatogen CerviPan HPV qPCR Screening Kit

by Pharmali̇ne Sağlik Hi̇zmetleri̇ Sanayi̇ Ti̇caret Anoni̇m Şi̇rketi̇ EUDAMED

Active European Union

Ref PHCPN-50Model UniPatogen CerviPan HPV qPCR Screening Kit

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberIQMS/00009/0v001 Date6 Jul 2026IssuedStatusActive expires 5 Jul 2031

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  • Withdrawn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)
  • IQMS/00009/0v001 Issued

    Quality management system EU IVDR

    Notified body
    QMD Services GmbH 2962
    Issued
    6 Jul 2026
    Expires
    5 Jul 2031

Specification

EUDAMED

Model / Reference
UniPatogen CerviPan HPV qPCR Screening Kit, PHCPN-50
Primary DI / UDI-DI
08699863071726
Basic UDI-DI
869986307PHCPNZM
EMDN Code
W0105041002 Screening high-risk hpv - na reagents
Device Class
Class C
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000019285

Other devices from Pharmali̇ne Sağlik Hi̇zmetleri̇ Sanayi̇ Ti̇caret Anoni̇m Şi̇rketi̇

Properties

  • Reagent
  • Professional Testing

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No