Automatic Luminescence Immunoassay Analyzer
by Autobio Labtec Instruments Co., Ltd. China EUDAMED
Ref 07061Model AutoLumo A6000、AutoLumo A6200、AutoLumo A6600、AutoLumo A6800
EMDN W0201020103
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697304909Model72UP | Date14 Mar 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Model / Reference
- AutoLumo A6000、AutoLumo A6200、AutoLumo A6600、AutoLumo A6800, 07061
- Primary DI / UDI-DI
- 06973049096881
- Basic UDI-DI
- 697304909Model72UP
- Direct Marketing DI
- 06973049096881
- EMDN Code
- W0201020103 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
- Device Class
- Class A
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- CN-MF-000012110
- Authorised representative
- Obelis s.a. BE-AR-000000106
Other devices from Autobio Labtec Instruments Co., Ltd.
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
- New Device: No
Sources (1)
- EUDAMED 6425ff5e-1bf4-44e4-a1be-52db9491ad27