AnteCRC
by OÜ Antegenes Estonia EUDAMED
Ref AnteCRC
EMDN W02050192
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-04745010362026 | Date25 Apr 2023 | StatusActive |
Coverage
- Expiring (legacy directive)
- Not covered
European Union — CE/IVDD Expiring (legacy directive)
Specification
- Device Name
- AnteCRC, colorectal cancer polygenic risk score test
- Model / Reference
- AnteCRC
- Primary DI / UDI-DI
- 04745010362026
- Basic UDI-DI
- B-04745010362026
- EMDN Code
- W02050192 Nucleic acid testing instruments except micro-arrays - IVD medical device software
- Device Class
- Class IVD General
- Market of Registration
- Estonia
Manufacturer details
- EUDAMED SRN
- EE-MF-000028961
Other devices from OÜ Antegenes
Properties & raw data
Show properties, registry sources and raw records
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
Sources (1)
- EUDAMED abf67a51-9efe-45e5-a7a1-50f57f802032