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Lp-PLA2 Calibrator Mini-Kit

by Techno-path Manufacturing Ltd. Ireland EUDAMED

Ref PLA2-MCAL

EMDN W0102152204

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-05391523441162 Basic UDI-DIDate5 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
PLA2-MCAL
Primary DI / UDI-DI
05391523441162
Basic UDI-DI
B-05391523441162
EMDN Code
W0102152204 Cardiac marker standards and calibrators
Device Class
Class IVD General
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
IE-MF-000001822

Other devices from Techno-Path Manufacturing

See all devices from Techno-Path Manufacturing →

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Professional Testing
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 85039cf3-7dd5-4350-a291-d2c496c76930 61 fields · synced 23 Oct 2026