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Automatic Chemiluminescence Immunoassay Analyzer
EUDAMEDClass A (EU MDR)
Ref QD0301Model LA 3000
Identity
- Trade Name
- Automatic Chemiluminescence Immunoassay Analyzer EUDAMED
- Device Name
- Automatic Chemiluminescence Immunoassay Analyzer EUDAMED
- Model / Reference
- LA 3000 EUDAMEDQD0301 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970522640043 EUDAMED
- Basic UDI-DI
- 697052264YQ08KV EUDAMED
- EMDN Code
- W0201020103 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Automatic Chemiluminescence Immunoassay Analyzer by Sichuan Orienter Biotechnology Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697052264YQ08KV | Class A | Active |
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Manufacturer
- Manufacturer
- Sichuan Orienter Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000003026
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED f229ff32-7034-419e-8e0f-dab56e5658c6 61 fields · synced Oct 6, 2026