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Phosphorylated Tau 217 Protein Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref 100tests/kitModel Reagents (include Calibrator 2x1mL/bottle and Control 2x1mL/bottle) 100tests/kitRef 50tests/kitModel Reagents (include Calibrator 1x1mL/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 1x1mL/bottle) 50tests/kitModel Reagents (include Calibrator 1x1mL/bottle and Control 2x1mL/bottle) 100tests/kit
Identity
- Device Name
- Phosphorylated Tau 217 Protein Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- Reagents (include Calibrator 2x1mL/bottle and Control 2x1mL/bottle) 100tests/kit EUDAMED100tests/kit EUDAMEDReagents (include Calibrator 1x1mL/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 1x1mL/bottle) 50tests/kit EUDAMEDReagents (include Calibrator 1x1mL/bottle and Control 2x1mL/bottle) 100tests/kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972719605651 EUDAMED06972719603510 EUDAMED06972719603527 EUDAMED06972719603503 EUDAMED06972719603534 EUDAMED
- Basic UDI-DI
- B-06972719605651 EUDAMEDB-06972719603510 EUDAMEDB-06972719603527 EUDAMEDB-06972719603503 EUDAMEDB-06972719603534 EUDAMED
- EMDN Code
- W0102019099 SPECIFIC PROTEINS - OTHER 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
Phosphorylated Tau 217 Protein 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-06972719605651 | 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 67fa8e76-109a-4214-ad90-37f28e3dac40 61 fields · synced Oct 6, 2026
- EUDAMED 0be86490-3f40-4f5c-a462-a4ee57f2b10a 61 fields · synced May 16, 2026
- EUDAMED 624fce8f-b5ef-488b-bac9-cf2bcd178d87 61 fields · synced May 16, 2026
- EUDAMED 712542b9-ee4a-4823-a4f5-db31371097f7 61 fields · synced May 17, 2026
- EUDAMED 0f450235-6770-4ad3-9a3b-63089b608147 61 fields · synced May 19, 2026