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Carbohydrate Antigen 19-9 Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref 215830001Model Reagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle): 100tests/kit
Identity
- Device Name
- Carbohydrate Antigen 19-9 Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- Reagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle): 100tests/kit EUDAMED215830001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972719600724 EUDAMED
- Basic UDI-DI
- B-06972719600724 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-06972719600724 | 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 (1)
- EUDAMED 1d3e7028-9890-4271-ba83-08c1a2767b29 61 fields · synced Jun 18, 2026