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Amyloid β Protein 1-40 Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref 100tests/kitModel Reagents (include Calibrator 1x1mL/bottle and Control 2x1mL/bottle) 100tests/kitRef 50tests/kitModel Reagents (include Calibrator 2x1mL/bottle and Control 2x1mL/bottle) 50tests/kitModel Reagents（include Calibrator 1x1mL/bottle and Control 1x1mL/bottle )100tests/kitModel Reagents (include Calibrator 1x1mL/bottle and Control 2x1mL/bottle) 50tests/kitModel Reagents (include Calibrator 2x1mL/bottle and Control 2x1mL/bottle) 100tests/kit
Identity
- Device Name
- Amyloid β Protein 1-40 Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- Reagents (include Calibrator 1x1mL/bottle and Control 2x1mL/bottle) 100tests/kit EUDAMED100tests/kit EUDAMEDReagents (include Calibrator 2x1mL/bottle and Control 2x1mL/bottle) 50tests/kit EUDAMED50tests/kit EUDAMEDReagents（include Calibrator 1x1mL/bottle and Control 1x1mL/bottle )100tests/kit EUDAMEDReagents (include Calibrator 1x1mL/bottle and Control 2x1mL/bottle) 50tests/kit EUDAMEDReagents (include Calibrator 2x1mL/bottle and Control 2x1mL/bottle) 100tests/kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972719603497 EUDAMED06972719605620 EUDAMED06972719603480 EUDAMED06972719603473 EUDAMED06972719605637 EUDAMED
- Basic UDI-DI
- B-06972719603497 EUDAMEDB-06972719605620 EUDAMEDB-06972719603480 EUDAMEDB-06972719603473 EUDAMEDB-06972719605637 EUDAMED
- EMDN Code
- W0102019013 BETA-AMYLOID (1-40) 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
Amyloid β Protein 1-40 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-06972719603497 | 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 (5)
- EUDAMED d35a296e-d3b1-4281-a447-274f2bb0cf0e 61 fields · synced Oct 8, 2026
- EUDAMED 1f75758a-f95d-4337-80e6-cf090de37c5e 61 fields · synced May 17, 2026
- EUDAMED 9e847082-97d6-4d21-a8d8-043a51dab8f8 61 fields · synced May 18, 2026
- EUDAMED ea3a0f35-fae5-484a-990a-ed791487dfae 61 fields · synced May 18, 2026
- EUDAMED 5094a98c-905d-4c18-9639-debb62c3ca35 61 fields · synced May 19, 2026