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TERT Promoter Mutation Detection Kit（Real-time PCR Assays）

by Gold Probe Diagnostic Biotechnology Inc. MF EUDAMED

Active European Union

Ref 600030

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06975977070308 Basic UDI-DIDate11 Dec 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  • Withdrawn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
TERT Promoter Mutation Detection Kit（Real-time PCR Assays）
Model / Reference
600030
Primary DI / UDI-DI
06975977070308
Basic UDI-DI
B-06975977070308
EMDN Code
W01060299 Tests for acquired genetic or chromosomal alterations - other
Device Class
Class IVD General
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000031524
Authorised representative
Lotus NL B.V. NL-AR-000000121

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Properties

  • Animal Tissues
  • Reagent
  • Near-Patient Testing
  • Professional Testing

Other properties (6)

  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No