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Chemiluminescence Immunoassay Analyzer
EUDAMEDClass A (EU MDR)
Ref 02-12-02-0004-00Model EXI 1800, EXI 1810, EXI 1820, EXI 1830Ref 02-12-02-0011-00
by Zybio Inc.
Identity
- Device Name
- Chemiluminescence Immunoassay Analyzer EUDAMED
- Model / Reference
- EXI 1800, EXI 1810, EXI 1820, EXI 1830 EUDAMED02-12-02-0004-00 EUDAMED02-12-02-0011-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973262866131 EUDAMED06973262866155 EUDAMED
- Basic UDI-DI
- 69732628600007ZL EUDAMED
- EMDN Code
- W0201020102 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands 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
Chemiluminescence Immunoassay Analyzer by Zybio Inc. — 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 | 69732628600007ZL | Class A | Active |
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Manufacturer
- Manufacturer
- Zybio Inc.
- EUDAMED SRN
- CN-MF-000003349
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED dde0c567-a959-4fd7-8125-e89b8e4b35db 61 fields · synced Jul 14, 2026
- EUDAMED d5dfcbcf-35bd-493c-a9de-2393b74137ad 61 fields · synced May 18, 2026