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Lipoprotein-associated Phospholipase A2 Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref 100tests/kitModel Reagents (include Calibrator 1x1mL/bottle and Control 2x1mL/bottle) 100tests/kit
Identity
- Device Name
- Lipoprotein-associated Phospholipase A2 Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- Reagents (include Calibrator 1x1mL/bottle and Control 2x1mL/bottle) 100tests/kit EUDAMED100tests/kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972719601660 EUDAMED
- Basic UDI-DI
- B-06972719601660 EUDAMED
- EMDN Code
- W01021312 LIPOPROTEIN-ASSOCIATED PHOSPHOLIPASE A2 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
Lipoprotein-associated Phospholipase A2 Chemiluminescence Immunoassay Kit by Nanjing RealMind Biotech Co., Ltd. — Class IVD General — CE/MDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-06972719601660 | 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 b9a1e397-91ea-4882-a7d6-02e991f43117 61 fields · synced Oct 6, 2026