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Phosphorylated Tau 181 Protein Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref S2046E-50Ref S2046E-200Ref S2046E-150Ref S2046E-100
Identity
- Device Name
- Phosphorylated Tau 181 Protein Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2046E-50 EUDAMEDS2046E-200 EUDAMEDS2046E-150 EUDAMEDS2046E-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792739598 EUDAMED06955792739635 EUDAMED06955792739628 EUDAMED06955792739611 EUDAMED
- Basic UDI-DI
- B-06955792739598 EUDAMEDB-06955792739635 EUDAMEDB-06955792739628 EUDAMEDB-06955792739611 EUDAMED
- EMDN Code
- W0102019017 PHOSPHORYLATED TAU (PTAU) 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
Phosphorylated Tau 181 Protein 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-06955792739598 | 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 (4)
- EUDAMED f411037c-7bd1-419e-aa3f-ef808a34e012 61 fields · synced Oct 5, 2026
- EUDAMED 291394db-2f36-4803-8826-4c44ca00d6c3 61 fields · synced May 18, 2026
- EUDAMED d250075d-ad1e-4741-b41e-3e2a831a650b 61 fields · synced May 18, 2026
- EUDAMED 25f4194a-5612-444b-be89-b6b95ef47adf 61 fields · synced May 18, 2026