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Cancer Antigen 50 Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref 215870001Model Reagents (include Calibrator and Control): 100tests/kitRef 50tests/kitModel Reagents（include Calibrator 1x1mL/bottle and Control 2x1mL/bottle )50tests/kitModel Reagents（include Calibrator 2x1mL/bottle and Control 2x1mL/bottle ) 50tests/kitModel Reagents（include Calibrator 1x1mL/bottle and Control 1x1mL/bottle )50tests/kit
Identity
- Device Name
- Cancer Antigen 50 Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- Reagents (include Calibrator and Control): 100tests/kit EUDAMED215870001 EUDAMEDReagents（include Calibrator 1x1mL/bottle and Control 2x1mL/bottle )50tests/kit EUDAMED50tests/kit EUDAMEDReagents（include Calibrator 2x1mL/bottle and Control 2x1mL/bottle ) 50tests/kit EUDAMEDReagents（include Calibrator 1x1mL/bottle and Control 1x1mL/bottle )50tests/kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972719600694 EUDAMED06972719607815 EUDAMED06972719607822 EUDAMED06972719607808 EUDAMED
- Basic UDI-DI
- B-06972719600694 EUDAMEDB-06972719607815 EUDAMEDB-06972719607822 EUDAMEDB-06972719607808 EUDAMED
- EMDN Code
- W0102030104 CANCER ANTIGEN 50 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Hungary EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Cancer Antigen 50 Chemiluminescence Immunoassay Kit by Nanjing RealMind Biotech Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06972719600694 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Nanjing RealMind Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000024838
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (4)
- EUDAMED 13308a0f-0c8f-4e40-98c0-7440b136c9b6 61 fields · synced Oct 6, 2026
- EUDAMED f5bc1d62-2a31-439d-bf40-50d00f17472c 61 fields · synced Jul 9, 2026
- EUDAMED 5a987269-5f87-4f49-bd69-92733565e98c 61 fields · synced Aug 1, 2026
- EUDAMED b5f6387d-7acc-4301-8d7f-9b565addf937 61 fields · synced Aug 4, 2026