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Amyloid β Protein 1-42 Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref S2003E-50Ref S2003E-150Ref S2003E-75Ref S2003E-25
Identity
- Device Name
- Amyloid β Protein 1-42 Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2003E-50 EUDAMEDS2003E-150 EUDAMEDS2003E-75 EUDAMEDS2003E-25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792736412 EUDAMED06955792736443 EUDAMED06955792736429 EUDAMED06955792736405 EUDAMED
- Basic UDI-DI
- B-06955792736412 EUDAMEDB-06955792736443 EUDAMEDB-06955792736429 EUDAMEDB-06955792736405 EUDAMED
- EMDN Code
- W0102019014 BETA-AMYLOID (1-42) 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
Amyloid β Protein 1-42 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-06955792736412 | 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 (7)
- EUDAMED 164a6eb0-21b1-4ca2-a33a-a57f360eec05 61 fields · synced Jul 20, 2026
- EUDAMED a952a1a1-a726-40d7-9f1c-57185bff5a05 61 fields · synced May 17, 2026
- EUDAMED 0292be2f-1ad4-4b20-9bf8-a310dad6ed39 61 fields · synced May 17, 2026
- EUDAMED 94fad3ca-0eba-4bce-ab85-1b96b4fe5a09 61 fields · synced May 19, 2026
- EUDAMED f0d1e2f8-cd24-4a91-9e01-e61bff7f6328 61 fields · synced Jun 18, 2026
- EUDAMED 89551f91-7f8f-4848-9dfb-3cd17269e855 61 fields · synced Jul 9, 2026
- EUDAMED 6b39d75a-1aaf-4f33-bca4-5c5729a6fa1f 61 fields · synced Jul 20, 2026