Certai̇n
by Koroglu Medikal Tibbi Malzemeleri Kozmetik Ithalat Ihracat Sanayi Ve Ticaret Ltd. Sti. 2 variants
Ref CHCG.01
Active
CE IVDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-08699195610426 08699195610426 | Date12 Oct 2026 | StatusActive |
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- Withdrawn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
- Certain Gebelik Testi
- Model / Reference
- CHCG.01
- Primary DI / UDI-DI
- 08699195610426
- Basic UDI-DI
- B-08699195610426
- EMDN Code
- W0102050213, W0102160302
- Device Class
- Class IVD General
- EU market of registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- TR-MF-000032257
Other devices from Koroglu Medikal Tibbi Malzemeleri Kozmetik Ithalat Ihracat Sanayi Ve Ticaret Ltd. Sti.
Properties
Other properties (6)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Near-Patient Testing: No
- Companion Diagnostics: No