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Plasmin-Alpha 2 Plasmin Inhibitor Complex Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref S2048E-200Ref S2048E-25Ref S2048E-75
Identity
- Device Name
- Plasmin-Alpha 2 Plasmin Inhibitor Complex Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2048E-200 EUDAMEDS2048E-25 EUDAMEDS2048E-75 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792739758 EUDAMED06955792739703 EUDAMED06955792739727 EUDAMED
- Basic UDI-DI
- B-06955792739758 EUDAMEDB-06955792739703 EUDAMEDB-06955792739727 EUDAMED
- EMDN Code
- W01029099 IMMUNOCHEMISTRY REAGENTS - OTHER 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
Plasmin-Alpha 2 Plasmin Inhibitor Complex 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-06955792739758 | 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 6caf4ef7-8d4a-44a0-b92a-5c19b82931fb 61 fields · synced Jul 31, 2026
- EUDAMED 0f138150-3f74-44f1-aa6f-dcd11f610e0d 61 fields · synced May 19, 2026
- EUDAMED ed982bb4-f478-4c29-9a29-fbd508ace6c3 61 fields · synced May 19, 2026