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D-Dimer 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 1x1mL/bottle and Control 1x1mL/bottle) 50tests/kitModel Reagents (include Calibrator 2x1mL/bottle and Control 2x1mL/bottle) 50tests/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
- D-Dimer Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- Reagents (include Calibrator 1x1mL/bottle and Control 2x1mL/bottle) 100tests/kit EUDAMED100tests/kit EUDAMEDReagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle) 50tests/kit EUDAMED50tests/kit EUDAMEDReagents (include Calibrator 2x1mL/bottle and Control 2x1mL/bottle) 50tests/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
- 06972719601882 EUDAMED06972719601530 EUDAMED06972719604807 EUDAMED06972719604814 EUDAMED06972719601875 EUDAMED
- Basic UDI-DI
- B-06972719601882 EUDAMEDB-06972719601530 EUDAMEDB-06972719604807 EUDAMEDB-06972719604814 EUDAMEDB-06972719601875 EUDAMED
- EMDN Code
- W0103020503 D-DIMER 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
D-Dimer Chemiluminescence Immunoassay Kit by Nanjing RealMind Biotech Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06972719601882 | 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 ece8a015-d4e0-4aaa-b667-7c060eb41ab5 61 fields · synced Oct 6, 2026
- EUDAMED 6763b2d4-7e1b-4201-bcf5-e6eb0e7cd99b 61 fields · synced May 17, 2026
- EUDAMED 19f5c6d8-7b84-4fa6-9547-bb02ef4be496 61 fields · synced May 17, 2026
- EUDAMED 174b3bb1-e6d3-48de-b468-a0d175e7eb90 61 fields · synced May 17, 2026
- EUDAMED 259993fa-de04-4980-936f-a2e8c0a89dcf 61 fields · synced May 19, 2026