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Mobile Phase 002

by ARCHImedline GmbH Austria EUDAMED

Ref M002-01

EMDN W01019099

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number1912013223M002G7 Basic UDI-DIDate27 Jul 2026RegisteredStatusActive

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
M002-01
Primary DI / UDI-DI
09120132230111
Basic UDI-DI
1912013223M002G7
Direct Marketing DI
09120132230111
EMDN Code
W01019099 Clinical chemistry reagents - other
Device Class
Class A
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
  • Reagent
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED d4444ab7-9d2b-411d-a938-b1500afd3fad 61 fields · synced 22 Oct 2026