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Twist Precision Exome Dx Kit, 16 samples - Box 1

by Twist Bioscience Corporation United States EUDAMED

Ref 104989 EMDN W010699

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number081011955TPEDxK9V Basic UDI-DIDate9 Jan 2024RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Twist Precision Exome Dx Kit
Model / Reference
104989
Primary DI / UDI-DI
00810119550019
Basic UDI-DI
081011955TPEDxK9V
EMDN Code
W010699 Genetic tests - other
Device Class
Class A
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000039181
Authorised representative
QAdvis EAR AB SE-AR-000001599

Other devices from Twist Bioscience Corporation

See all devices from Twist Bioscience Corporation →

Properties & raw data

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

Sources (1)

  • EUDAMED f239103b-9716-4b30-99d3-8db953054a67 61 fields · synced 22 Oct 2026