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Fully Automated Indirect Immunofluorescence Analyser
EUDAMEDClass A (EU MDR)
Ref LUMIQ-KR-IFA-001Model QuantIFA 2000
Identity
- Device Name
- Fully Automated Indirect Immunofluorescence Analyser EUDAMED
- Model / Reference
- QuantIFA 2000 EUDAMEDLUMIQ-KR-IFA-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06926980312411 EUDAMED
- Basic UDI-DI
- 69269803YQIFA2000V3 EUDAMED
- EMDN Code
- W0299 IVD INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Austria 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
Yes
EUDAMED
Fully Automated Indirect Immunofluorescence Analyser by Guangzhou Kangrun Biotech 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 | 69269803YQIFA2000V3 | Class A | Active |
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Manufacturer
- Manufacturer
- Guangzhou Kangrun Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000032267
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (1)
- EUDAMED bed1dc80-967e-4716-9508-78a351dce9a4 61 fields · synced Jul 9, 2026