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Fagron TeloTest

by Fagron Genomics Spain EUDAMED

Ref FGMS-Telo

EMDN W02050292

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number8437024682FGMS-TeloT3 Basic UDI-DIDate15 Jun 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Fagron TeloTest
Model / Reference
FGMS-Telo
Primary DI / UDI-DI
13 52022 FGMS-TELO 1 16
Basic UDI-DI
8437024682FGMS-TeloT3
Direct Marketing DI
13 52022 FGMS-TELO 1 16
EMDN Code
W02050292 Micro-array instruments - IVD medical device software
Device Class
Class C
Special Device Type
Software
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000001092

Other devices from Fagron Genomics

Properties & raw data

Show properties, registry sources and raw records
Other properties (11)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED c54e2034-fb17-4867-916b-916da5a71df9 61 fields · synced 22 Oct 2026