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Carbohydrate Antigen 19-9 Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref 50tests/kitModel Reagents（include Calibrator 1x1mL/bottle and Control 1x1mL/bottle )50tests/kitRef 100tests/kitModel Reagents（include Calibrator 1x1mL/bottle and Control 2x1mL/bottle )100tests/kitModel Reagents（include Calibrator 2x1mL/bottle and Control 2x1mL/bottle )100tests/kitModel Reagents（include Calibrator 1x1mL/bottle and Control 2x1mL/bottle )50tests/kit
Identity
- Device Name
- Carbohydrate Antigen 19-9 Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- Reagents（include Calibrator 1x1mL/bottle and Control 1x1mL/bottle )50tests/kit EUDAMED50tests/kit EUDAMEDReagents（include Calibrator 1x1mL/bottle and Control 2x1mL/bottle )100tests/kit EUDAMED100tests/kit EUDAMEDReagents（include Calibrator 2x1mL/bottle and Control 2x1mL/bottle )100tests/kit EUDAMEDReagents（include Calibrator 1x1mL/bottle and Control 2x1mL/bottle )50tests/kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972719602841 EUDAMED06972719602834 EUDAMED06972719604395 EUDAMED06972719602858 EUDAMED
- Basic UDI-DI
- B-06972719602841 EUDAMEDB-06972719602834 EUDAMEDB-06972719604395 EUDAMEDB-06972719602858 EUDAMED
- EMDN Code
- W0102030103 CANCER ANTIGEN 19-9 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
Carbohydrate Antigen 19-9 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-06972719602841 | 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 8dcc3de8-9c7e-40c3-ae8f-a47d192996ae 61 fields · synced Oct 6, 2026
- EUDAMED 688b2ed9-c54a-43a7-9225-198a51386679 61 fields · synced May 18, 2026
- EUDAMED d2a24956-c37e-41b6-bc24-3c3a88aaed79 61 fields · synced May 18, 2026
- EUDAMED bfdb8065-9fdf-440f-b6b0-1d1b17029e91 61 fields · synced May 19, 2026