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Calibrator set – Level 0 – 6 for PEth from whole blood

by ARCHImedline GmbH

Ref A371-011

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number1912013223A371-011VR Basic UDI-DI 09120132230180UDI-DIDate28 Jul 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Model / Reference
A371-011
Primary DI / UDI-DI
09120132230180
Basic UDI-DI
1912013223A371-011VR
Direct Marketing DI
09120132230180
EMDN Code
W0101050301 Calibrators multicomponent (cc)
Device Class
Class B
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
AT-MF-000037501

Other devices from ARCHImedline GmbH

See all devices from ARCHImedline GmbH →

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