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SARS-CoV-2 and E484A/Q954H Mutant Nucleic Acid Multiplex Detection Kit (Fluorescence PCR Method)

by Suzhou TianLong Biotechnology Co., Ltd. EUDAMED

Active European Union

Ref P762H

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974858560808 Basic UDI-DIDate26 Jul 2023RegisteredStatusActive

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  • Withdrawn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

Device Name
SARS-CoV-2 and E484A/Q954H Mutant Nucleic Acid Multiplex Detection Kit (Fluorescence PCR Method)
Model / Reference
P762H
Primary DI / UDI-DI
06974858560808
Basic UDI-DI
B-06974858560808
EMDN Code
W0105040519
Device Class
Class IVD General
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000001080
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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Properties

Show properties
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No