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13 Types of High-Risk Human Papillomavirus Nucleic Acid Detection Kit (PCR-Fluorescent Probe）

by Triplex International Biosciences (China) Co., LTD. China EUDAMED

Ref C011937

EMDN W0105041002

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06950917910562 Basic UDI-DIDate23 Oct 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
13 Types of High-Risk Human Papillomavirus Nucleic Acid Detection Kit (PCR-Fluorescent Probe）
Model / Reference
C011937
Primary DI / UDI-DI
06950917910562
Basic UDI-DI
B-06950917910562
EMDN Code
W0105041002 Screening high-risk hpv - na reagents
Device Class
Class IVD General
Market of Registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000001097
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Triplex International Biosciences (China) Co., LTD.

See all devices from Triplex International Biosciences (China) Co., LTD. →

Properties & raw data

Show properties, registry sources and raw records
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 89347487-c605-4ee9-abb3-7601c8310d34 61 fields · synced 22 Oct 2026