CeliaSCAN
Ref 2331633Model CeliaSCAN
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-08719327031834 | Date15 May 2023 | 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- Withdrawn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
- Model / Reference
- 2331633, CeliaSCAN
- Primary DI / UDI-DI
- 08719327031834, D-2331633WJ, 87202998644054
- Basic UDI-DI
- B-08719327031834, B-2331633WJ, B-87202998644054
- EMDN Code
- W010699 Genetic tests - other
- Device Class
- Class IVD General
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- NL-MF-000005727
Properties
Other properties (8)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No