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Lp-PLA2 Control
EUDAMEDClass IVD General (EU MDR)
Ref W-C-Lp-PLA2-1Model C1: 1*1 mL C2: 1*1 mL
Identity
- Device Name
- Lp-PLA2 Control EUDAMED
- Model / Reference
- C1: 1*1 mL C2: 1*1 mL EUDAMEDW-C-Lp-PLA2-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978896416219 EUDAMED
- Basic UDI-DI
- B-06978896416219 EUDAMED
- EMDN Code
- W0102152099 CONTROLS- IMMUNOCHEMISTRY - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Romania EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Lp-PLA2 Control by Wuhan Easydiagnosis Biomedicine 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-06978896416219 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Wuhan Easydiagnosis Biomedicine Co., Ltd.
- EUDAMED SRN
- CN-MF-000019908
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED de2eb076-a7cd-4881-9cf4-29a4f038f7cf 61 fields · synced Oct 6, 2026