Copper Reagent Kit
by Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇
Ref K46540
Copper Reagent Kit (K46540) is an in vitro diagnostic device (EU IVDD general IVD; EMDN category copper) made by Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇, registered in EUDAMED on 2 Nov 2026 (Basic UDI-DI B-08683555630599), active as of 7 Nov 2026.
Active
CE IVDD
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-08683555630599 08683555630599 | Date2 Nov 2026 | StatusActive |
Official records
- EUDAMED public site B-08683555630599
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDD Active
Specification
- Device name
- Bakır Testi
- Model / reference
- K46540
- Primary DI / UDI-DI
- 08683555630599
- Basic UDI-DI
- B-08683555630599
- EMDN code
- W01010206 Copper
- Device class
- Class IVD General
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- TR-MF-000040334
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