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Serum Amyloid A Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref S2151E-200Ref S2151E-100
Identity
- Device Name
- Serum Amyloid A Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2151E-200 EUDAMEDS2151E-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792742895 EUDAMED06955792742871 EUDAMED
- Basic UDI-DI
- B-06955792742895 EUDAMEDB-06955792742871 EUDAMED
- EMDN Code
- W0102019013 BETA-AMYLOID (1-40) 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
Serum Amyloid A Chemiluminescence Immunoassay Kit by Sansure Biotech Inc. — 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-06955792742895 | 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 (2)
- EUDAMED 7837ca2f-55ec-4248-9ae7-6a913c013834 61 fields · synced Sep 17, 2026
- EUDAMED 2e5741dd-e806-47c7-a88c-1642518dc1e9 61 fields · synced May 17, 2026