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CFΔ Collection System

by Utsat Sağlik Teknoloji̇leri̇ Sanayi̇ Ti̇caret Li̇mi̇ted Şi̇rketi̇ Türkiye EUDAMED

Ref CTL3

EMDN W0101050302

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number86992260CTL3(130)YZ Basic UDI-DIDate23 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
LINEARISATION SOLUTION 130 (118-142)mmol/L NaCl
Model / Reference
CTL3
Primary DI / UDI-DI
08699226000103
Basic UDI-DI
86992260CTL3(130)YZ
Direct Marketing DI
08699226000103
EMDN Code
W0101050302 Calibrators single component (cc)
Device Class
Class A
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000016643

Other devices from Utsat Sağlik Teknoloji̇leri̇ Sanayi̇ Ti̇caret Li̇mi̇ted Şi̇rketi̇

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED ae27569d-038d-4e6e-a236-cdd7d98463f8 61 fields · synced 23 Oct 2026