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Automatic Chemiluminescence Immunoassay System
EUDAMEDClass A (EU MDR)
Ref ZD002
Identity
- Trade Name
- Automatic Chemiluminescence Immunoassay Analyzer EUDAMED
- Device Name
- Automatic Chemiluminescence Immunoassay System EUDAMEDAutomatic Chemiluminescence Immunoassay Analyzer EUDAMED
- Model / Reference
- ZD002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974969982650 EUDAMED
- Basic UDI-DI
- 697496998ZD002YF EUDAMED
- EMDN Code
- W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany 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 System by Biobase Diagnostic Technology (Shandong) Co., Ltd. — Class A — IVDR — listed in EUDAMED
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 | 697496998ZD002YF | Class A | Active |
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Manufacturer
- Manufacturer
- Biobase Diagnostic Technology (Shandong) Co., Ltd.
- EUDAMED SRN
- CN-MF-000025964
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (2)
- EUDAMED c2ef898b-fa1a-4cc6-bfda-99f53621204b 61 fields · synced Oct 6, 2026
- EUDAMED b0f97a76-b3ca-4e88-b225-3cb7c415c888 61 fields · synced Jul 18, 2026