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One Lambda Devyser Accept cfDNA

by Devyser AB Sweden EUDAMED

Ref 8-R114-8, 8-R114-24

EMDN W0106010499

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number7350040638R114RC Basic UDI-DIDate13 Mar 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
8-R114-8, 8-R114-24
Primary DI / UDI-DI
07350040631744, 07350040631751
Basic UDI-DI
7350040638R114RC
Direct Marketing DI
07350040631744
07350040631751
EMDN Code
W0106010499 Polymorphism tests - other
Device Class
Class C
Market of Registration
Sweden

Manufacturer details

EUDAMED SRN
SE-MF-000001699

Other devices from Devyser AB

See all devices from Devyser AB →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
  • New Device
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

Sources (2)

  • EUDAMED ec593265-0897-496b-973e-b17a5462f510 61 fields · synced 22 Oct 2026
  • EUDAMED 07350040631751|7350040638R114RC 61 fields · synced 19 May 2026