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Fluorescence Immunoassay Analyzer
EUDAMEDClass A (EU MDR)
Ref 02-11-01-0001-00Model Q8 Pro
by Zybio Inc.
Identity
- Device Name
- Fluorescence Immunoassay Analyzer EUDAMED
- Model / Reference
- Q8 Pro EUDAMED02-11-01-0001-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973262866117 EUDAMED
- Basic UDI-DI
- 69732628600006ZJ 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
Fluorescence 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 | 69732628600006ZJ | 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 (1)
- EUDAMED e55cd479-96fe-4bb1-a4f1-5da5e12b6b9e 61 fields · synced Jul 26, 2026