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Nucleic Acid Genotyping Kit for Human Papillomavirus 29 types(Flowcytometry Fluorescence Hybridization Method)

by Healgen Scientific Limited Liability Company EUDAMED

Active European Union

Ref 2HPV29A01

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-00810173656948 Basic UDI-DIDate21 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
2HPV29A01
Primary DI / UDI-DI
00810173656948
Basic UDI-DI
B-00810173656948
EMDN Code
W0105041005 Other hpv - na reagents
Device Class
Class IVD General
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
US-MF-000018839
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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Properties

Show properties
  • Human Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Animal Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No