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Automated Chemiluminescence Immunoassay Analyzer
EUDAMEDClass A (EU MDR)
Ref Immu F400LModel Immu F200C, Immu F220C, Immu F200L, Immu F220L, Immu F400L, Immu F600L
Identity
- Device Name
- Automated Chemiluminescence Immunoassay Analyzer EUDAMED
- Model / Reference
- Immu F200C, Immu F220C, Immu F200L, Immu F220L, Immu F400L, Immu F600L EUDAMEDImmu F400L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06926802608906 EUDAMED
- Basic UDI-DI
- 69268026ImmuF200C000001RF 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
Automated Chemiluminescence Immunoassay Analyzer by Medcaptain Medical Technology 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 | 69268026ImmuF200C000001RF | Class A | Active |
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Manufacturer
- Manufacturer
- Medcaptain Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005925
- Authorised Representative
- R Sight B.V. NL-AR-000010445
Sources (1)
- EUDAMED d7678685-76c7-48ab-9dd2-f9940a57a339 61 fields · synced Jun 11, 2026