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EB Virus Nucleic Acid Detection Kit (Fluorescence PCR Method)

by Suzhou TianLong Biotechnology Co., Ltd. EUDAMED

Active European Union

Ref P177H

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974858560297 Basic UDI-DIDate25 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  • Withdrawn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
EB Virus Nucleic Acid Detection Kit (Fluorescence PCR Method)
Model / Reference
P177H
Primary DI / UDI-DI
06974858560297
Basic UDI-DI
B-06974858560297
EMDN Code
W0105040403 Ebv - na reagents
Device Class
Class IVD General
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000001080
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Suzhou TianLong Biotechnology Co., Ltd.

See all devices from Suzhou TianLong Biotechnology Co., Ltd. →

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