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Automated Chemiluminescence Immunoassay Analyzer
EUDAMEDClass A (EU MDR)
Ref Immu F6Model Immu F6, Immu F6SRef Immu F6SRef Immu F220LModel Immu F200C, Immu F220C, Immu F200L, Immu F220L, Immu F400L, Immu F600LRef Immu F200CRef Immu F600LRef Immu F220C
Identity
- Trade Name
- Automated Chemiluminescence Immunoassay Analyzer EUDAMED
- Device Name
- Automated Chemiluminescence Immunoassay Analyzer EUDAMED
- Model / Reference
- Immu F6, Immu F6S EUDAMEDImmu F6 EUDAMEDImmu F6S EUDAMEDImmu F200C, Immu F220C, Immu F200L, Immu F220L, Immu F400L, Immu F600L EUDAMEDImmu F220L EUDAMEDImmu F200C EUDAMEDImmu F600L EUDAMEDImmu F220C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06926802602737 EUDAMED06926802602744 EUDAMED06926802608890 EUDAMED06926802608869 EUDAMED06926802608913 EUDAMED06926802608876 EUDAMED
- Basic UDI-DI
- 69268026ImmuF60001KS EUDAMED69268026ImmuF200C000001RF EUDAMED
- EMDN Code
- W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h) EUDAMEDW0201020102 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 | 69268026ImmuF60001KS | 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 (8)
- EUDAMED ee1dea9a-397c-4a39-ab8e-18ebfd017c9b 61 fields · synced Jul 27, 2026
- EUDAMED 4c0d9bfc-d162-4475-8e07-a7af39336b9e 61 fields · synced May 18, 2026
- EUDAMED d8c81e60-f197-4c96-b8de-4784bd049fbd 61 fields · synced Jun 18, 2026
- EUDAMED ab591e44-4adf-4799-aff6-cf771274764d 61 fields · synced Jul 11, 2026
- EUDAMED 62db808a-0859-4f5e-b07c-e62f738db791 61 fields · synced Jul 15, 2026
- EUDAMED 348f778c-2431-4fdc-933a-c5e6411d3c4f 61 fields · synced Jul 17, 2026
- EUDAMED 2910a13e-e31c-4ad2-8dea-ba8225d6e81a 61 fields · synced Jul 21, 2026
- EUDAMED 5c63cda0-6191-4702-9668-45a167cb18b1 61 fields · synced Jul 27, 2026