Skip to content

CFΔ Collection System

by Utsat Sağlik Teknoloji̇leri̇ Sanayi̇ Ti̇caret Li̇mi̇ted Şi̇rketi̇ Türkiye EUDAMED

Ref CTL2

EMDN W0101050302

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number86992260CTL2(70)UP 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 70(64-76) mmol/L NaCl
Model / Reference
CTL2
Primary DI / UDI-DI
08699226000097
Basic UDI-DI
86992260CTL2(70)UP
Direct Marketing DI
08699226000097
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 fe63a7f1-4850-437a-ab0a-a1a7fe636a1a 61 fields · synced 23 Oct 2026