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Herpes Simplex Virus (HSV) II Nucleic Acid Detection Kit (Fluorescence PCR Method)

by Suzhou TianLong Biotechnology Co., Ltd. EUDAMED

Active European Union

Ref P106H

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974858560150 Basic UDI-DIDate25 Jul 2023RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
Herpes Simplex Virus (HSV) II Nucleic Acid Detection Kit (Fluorescence PCR Method)
Model / Reference
P106H
Primary DI / UDI-DI
06974858560150
Basic UDI-DI
B-06974858560150
EMDN Code
W0105040311 Hsv - 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.

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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