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Devyser Compact

by Devyser AB Sweden EUDAMED

Ref 8-A017.3-100 , 8-R017-25, 8-R017-100, 8-R017-50, 8-A017.3-100

EMDN W0106010399

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD Number7350040638A017MN Basic UDI-DIDate22 Apr 2022RegisteredStatusActive
European UnionCE/IVDR Number7350040638A017MN Basic UDI-DIDate22 Apr 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDD, CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Trade Name
Devyser Compact
Devyser Compact v3
Model / Reference
8-A017.3-100, 8-R017-25, 8-R017-100, 8-R017-50
Primary DI / UDI-DI
07350040630556, 07350040631218, 07350040631232, 07350040631225
Basic UDI-DI
7350040638A017MN, B-07350040630556
Direct Marketing DI
07350040631218
07350040631232
07350040631225
EMDN Code
W0106010399 Chromosomal disorders tests - other
Device Class
Class C
Class IVD General
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 NoEUDAMEDYesEUDAMED
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 (5)

  • EUDAMED c51e5b28-656f-4b77-a03e-01b73ff29bc7 61 fields · synced 22 Oct 2026
  • EUDAMED 07350040631218|7350040638A017MN 61 fields · synced 13 Jul 2026
  • EUDAMED 07350040631232|7350040638A017MN 61 fields · synced 24 Jul 2026
  • EUDAMED 07350040631225|7350040638A017MN 61 fields · synced 28 Jul 2026
  • EUDAMED 07350040630556|B-07350040630556 61 fields · synced 15 Oct 2026