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Calibrator 8 for PEth from whole blood

by ARCHImedline GmbH EUDAMED

Active European Union

Ref A371-082

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number1912013223A371-082WG Basic UDI-DIDate28 Jul 2026RegisteredStatusActive

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  • Withdrawn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

Model / Reference
A371-082
Primary DI / UDI-DI
09120132230340
Basic UDI-DI
1912013223A371-082WG
Direct Marketing DI
09120132230340
EMDN Code
W0101050301 Calibrators multicomponent (cc)
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

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