Identity
- Trade Name
- Sharay t-PAIC (CLIA) EUDAMED
- Device Name
- Sharay t-PAIC (CLIA) EUDAMED
- Model / Reference
- 18304001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975070762179 EUDAMED
- Basic UDI-DI
- B-06975070762179 EUDAMED
- EMDN Code
- W0103020507 TISSUE PLASMINOGEN ACTIVATOR EUDAMEDW0103020506 PLASMINOGEN ACTIVATOR-INHIBITORS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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
Sharay t-PAIC (CLIA) by C-Luminary Biotechnology 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-06975070762179 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- C-Luminary Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000035089
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (2)
- EUDAMED 05a37b0a-4997-4c9f-aa2d-8d248b5a7a2c 61 fields · synced Jul 25, 2026
- EUDAMED fe8496f4-d086-4ea6-a2ad-ec8228d3378b 61 fields · synced Jul 25, 2026