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Twist Precision Prep and Enrichment Dx Kit, 16 samples - Box 2

by Twist Bioscience Corporation EUDAMED

Active European Union

Ref 107658

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number081011955TPPEDxKLE Basic UDI-DIDate18 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  • Withdrawn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

Device Name
Twist Precision Prep and Enrichment Dx Kit
Model / Reference
107658
Primary DI / UDI-DI
00810119550088
Basic UDI-DI
081011955TPPEDxKLE
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

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Properties

Show properties
  • 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