CFΔ Collection System
by Utsat Sağlik Teknoloji̇leri̇ Sanayi̇ Ti̇caret Li̇mi̇ted Şi̇rketi̇ Türkiye EUDAMED
Ref CLHKL, UTS022, UCF2011, CAL90, UTS021, CTL1
EMDN Z12011385
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number86992260CLHKLWS | Date23 Mar 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Maintainance SolutionSweat Collection Kit / Ter Toplama Ki̇ti̇Sweat Chloride Analyzer / Terde Klor Anali̇zörüCALIBRATION SOLUTION 90(88-92) mmol/L NaClSweat Collection Apparatus with Disposable Adjustable StrapLINEARISATION SOLUTION 40(35-45) mmol/L NaCl
- Model / Reference
- CLHKL, UTS022, UCF2011, CAL90, UTS021, CTL1
- Primary DI / UDI-DI
- 08699226000158, 08699226000257, 08699226000196, 08699226000073, 08699226000110, 08699226000080
- Basic UDI-DI
- 86992260CLHKLWS, 86992260UTS0223J, 86992260UCF2011TW, 86992260CAL90RQ, 86992260UTS0213G, 86992260CTL1(40)TV
- Direct Marketing DI
- 086992260001580869922600025708699226000196086992260000730869922600011008699226000080
- EMDN Code
- Z12011385, W05019099, W0201040203, W0101050302
- 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
Other properties (8)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- New Device: No
Sources (6)
- EUDAMED c44de328-8bbd-4a15-a7e1-d04ef25d6748
- EUDAMED 08699226000257|86992260UTS0223J
- EUDAMED 08699226000196|86992260UCF2011TW
- EUDAMED 08699226000073|86992260CAL90RQ
- EUDAMED 08699226000110|86992260UTS0213G
- EUDAMED 08699226000080|86992260CTL1(40)TV