EUROLineCamera
by Euroimmun (Hangzhou) Medical Laboratory Diagnostics Co., Ltd
Ref CYQ-BL-ELCS-10-0102Model EUROLineCamera
Active
CE IVDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number69501910ELC00018U 06950191080128 | Date26 Sep 2025 | 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- Withdrawn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/IVDR Active
Specification
- Device Name
- EUROLineCamera
- Model / Reference
- EUROLineCamera, CYQ-BL-ELCS-10-0102
- Primary DI / UDI-DI
- 06950191080128
- Basic UDI-DI
- 69501910ELC00018U
- Direct Marketing DI
- 06950191080128
- EMDN Code
- W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
- Device Class
- Class A
Manufacturer details
- EUDAMED SRN
- CN-MF-000029679
- Authorised representative
- EUROIMMUN Medizinische Labordiagnostika AG DE-AR-000028774
Properties
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
- New Device: No