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Control-Set: (DBS Control-Set – Level I, II, III for Lyso Triplex)

by ARCHImedline GmbH Austria EUDAMED

Ref A290-012 EMDN W0101050299

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number1912013223A290-012VR Basic UDI-DIDate10 Jun 2025RegisteredStatusActive

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  • Withdrawn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
Control-Set: (DBS Control-Set – Level I, II, III for Lyso Triplex)
Model / Reference
A290-012
Primary DI / UDI-DI
09120132230036
Basic UDI-DI
1912013223A290-012VR
Direct Marketing DI
09120132230036
EMDN Code
W0101050299 Specific controls (cc) - other
Device Class
Class B
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
AT-MF-000037501

Other devices from ARCHImedline GmbH

See all devices from ARCHImedline GmbH →

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Professional Testing
  • New Device
Other properties (8)
  • Sterile: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED a1288470-3d4b-4f6e-98af-836edc2d193a 61 fields · synced 22 Oct 2026