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Tissue Plasminogen Activator/ Plasminogen Activator Inhibitor-1 Complex Chemilu…
EUDAMEDClass IVD General (EU MDR)
Ref S2064E-150Ref S2064E-200Ref S2064E-25
Identity
- Device Name
- Tissue Plasminogen Activator/ Plasminogen Activator Inhibitor-1 Complex Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2064E-150 EUDAMEDS2064E-200 EUDAMEDS2064E-25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792740662 EUDAMED06955792740679 EUDAMED06955792740624 EUDAMED
- Basic UDI-DI
- B-06955792740662 EUDAMEDB-06955792740679 EUDAMEDB-06955792740624 EUDAMED
- EMDN Code
- W0103020506 PLASMINOGEN ACTIVATOR-INHIBITORS 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
Tissue Plasminogen Activator/ Plasminogen Activator Inhibitor-1 Complex Chemilu… 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-06955792740662 | 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 1bcb8651-a0c1-4df9-9855-6bc34b8cf548 61 fields · synced Jul 22, 2026
- EUDAMED 5216912b-8ecb-4118-8e79-6b11630cb8d8 61 fields · synced May 18, 2026
- EUDAMED 04c81245-2244-4b42-9e9c-52d3a01ba2d6 61 fields · synced May 19, 2026