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Total IgE (CLIA)

by Maccura Biotechnology Co., Ltd. EUDAMED

Active European Union

Ref IM4403454, IM4407454, IM4402454, IM4406454Model 50 Tests; 100 Tests; 2×50 Tests; 2×100 Tests

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69506174IM440454DX Basic UDI-DIDate20 Sep 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

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.

Specification

EUDAMED

Model / Reference
50 Tests, 100 Tests, 2×50 Tests, 2×100 Tests, IM4403454, IM4407454, IM4402454, IM4406454
Primary DI / UDI-DI
06950617453482, 06950617453475, 06950617453468, 06950617453451
Basic UDI-DI
69506174IM440454DX
Direct Marketing DI
06950617453482
06950617453475
06950617453468
06950617453451
EMDN Code
W01020201 Immunoglobulin e - total
Device Class
Class B
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000014618
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Maccura Biotechnology Co., Ltd.

See all devices from Maccura Biotechnology Co., Ltd. →

Properties

  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No