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Lipoprotein-associated Phospholipase A2 Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref 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 1x1mL/bottle and Control 2x1mL/bottle) 50tests/kit
Identity
- Device Name
- Lipoprotein-associated Phospholipase A2 Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- Reagents (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 1x1mL/bottle and Control 2x1mL/bottle) 50tests/kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972719601653 EUDAMED06972719604739 EUDAMED06972719601639 EUDAMED
- Basic UDI-DI
- B-06972719601653 EUDAMEDB-06972719604739 EUDAMEDB-06972719601639 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 — 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-06972719601653 | 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 (3)
- EUDAMED 82dfa354-9b9c-41a5-b900-71c91abd956b 61 fields · synced Oct 6, 2026
- EUDAMED e983014b-e38d-4810-b6f6-6cab81002615 61 fields · synced May 19, 2026
- EUDAMED 4b081d8b-d812-42e7-814e-0f5642663ca6 61 fields · synced May 19, 2026