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IRMA Anti-Insulin(e)

by IMMUNOTECH s.r.o. Czech Republic EUDAMED

Ref A36473, A36474 EMDN W0102060104

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-A36473UZ Basic UDI-DIDate18 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
A36473, A36474
Primary DI / UDI-DI
D-A36473UZ
Basic UDI-DI
B-A36473UZ
EMDN Code
W0102060104 Insulin antibody
Device Class
Class IVD General
Market of Registration
Czechia

Manufacturer details

EUDAMED SRN
CZ-MF-000001761

Other devices from IMMUNOTECH s.r.o.

See all devices from IMMUNOTECH s.r.o. →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED D-A36473UZ|B-A36473UZ 61 fields · synced 24 Oct 2026