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ElisaRSR™ Fast ZnT8 Ab™

by RSR Limited EUDAMED

Active European Union

Ref FZTE/96

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-05056509600123 Basic UDI-DIDate28 Jun 2023RegisteredStatusActive

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  • Withdrawn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

Model / Reference
FZTE/96
Primary DI / UDI-DI
05056509600123
Basic UDI-DI
B-05056509600123
EMDN Code
W0102060108 Islet cell ab
Device Class
Class IVD General
Market of Registration
Malta

Manufacturer details

EUDAMED SRN
GB-MF-000025180
Authorised representative
Advena Limited MT-AR-000000234

Other devices from RSR Limited

See all devices from RSR Limited →

Properties

Show properties
  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No