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NEONATAL TSH Screening ELISA

by Zentech s.a. Belgium EUDAMED

Ref E-GP-192

EMDN W01020403

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-05425025460472 Basic UDI-DIDate23 Apr 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 24 Oct 2026

Device Name
NEONATAL TSH Screening ELISA
Model / Reference
E-GP-192
Primary DI / UDI-DI
05425025460472
Basic UDI-DI
B-05425025460472
EMDN Code
W01020403 Neonatal thyroid stimulating hormone
Device Class
Class IVD General
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
BE-MF-000001650

Other devices from Zentech s.a.

See all devices from Zentech s.a. →

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 170fffe6-765f-4fb8-ad94-0a9d5f3520f7 61 fields · synced 24 Oct 2026