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Lipoprotein-associated Phospholipase A2 Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref S2038E-25Ref S2038E-150Ref S2038E-200
Identity
- Device Name
- Lipoprotein-associated Phospholipase A2 Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2038E-25 EUDAMEDS2038E-150 EUDAMEDS2038E-200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792739109 EUDAMED06955792739147 EUDAMED06955792739154 EUDAMED
- Basic UDI-DI
- B-06955792739109 EUDAMEDB-06955792739147 EUDAMEDB-06955792739154 EUDAMED
- EMDN Code
- W01021312 LIPOPROTEIN-ASSOCIATED PHOSPHOLIPASE A2 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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
Lipoprotein-associated Phospholipase A2 Chemiluminescence Immunoassay Kit by Sansure Biotech Inc. — 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-06955792739109 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Sansure Biotech Inc.
- EUDAMED SRN
- CN-MF-000011392
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (3)
- EUDAMED dcd2e93c-7e48-4325-85d8-82dea1cce291 61 fields · synced Jul 26, 2026
- EUDAMED f0b84559-61ed-44cb-ad16-5f4cad18491c 61 fields · synced May 11, 2026
- EUDAMED 3a84468f-e5a8-46bf-8c87-284e7d67a2c8 61 fields · synced May 19, 2026