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Hepatitis Delta Realtime Pcr Kit

by Vircell, S.L

Ref RTPCR017-LPModel RTPCR017

Active European Union

CE IVDR

Valid until

22 Feb 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

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number843661029RTPCR017018R Basic UDI-DI 08436610290043UDI-DIDate10 Mar 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Model / Reference
RTPCR017, RTPCR017-LP
Primary DI / UDI-DI
08436610290043
Basic UDI-DI
843661029RTPCR017018R
EMDN Code
W0105020406 Hepatitis delta virus - na reagents
Device Class
Class D
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000004099

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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