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tPAI·C Tissue Plasminogen Activator-Plasminogen Activator Inhibitor-1 Complex (…
EUDAMEDClass IVD General (EU MDR)
Ref tPAI·C706-AE10Y, tPAI·C706-AE10N, tPAI·C706-AE20Y, tPAI·C706-AE20N
Identity
- Trade Name
- tPAI·C Tissue Plasminogen Activator-Plasminogen Activator Inhibitor-1 Complex (CLIA) EUDAMED
- Device Name
- tPAI·C Tissue Plasminogen Activator-Plasminogen Activator Inhibitor-1 Complex (CLIA) EUDAMED
- Model / Reference
- tPAI·C706-AE10Y, tPAI·C706-AE10N, tPAI·C706-AE20Y, tPAI·C706-AE20N EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-tPAIC706-AE5H EUDAMED
- Basic UDI-DI
- B-tPAIC706-AE5H EUDAMED
- EMDN Code
- W0103020507 TISSUE PLASMINOGEN ACTIVATOR EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain 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
tPAI·C Tissue Plasminogen Activator-Plasminogen Activator Inhibitor-1 Complex (… by Hangzhou Aichek Medical Technology Co., Ltd. — Class IVD General — IVDD…
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-tPAIC706-AE5H | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Aichek Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000028093
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (2)
- EUDAMED b55f6909-d3ed-415f-9501-a597e692d4bf 61 fields · synced Jul 30, 2026
- EUDAMED b55f6909-d3ed-415f-9501-a597e692d4bf-1 61 fields · synced Jun 10, 2026