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SARS-CoV-2 S-protein RBD IgG Antibody Test Kit (Chemiluminescence Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref S2150E-75Ref S2150E-50 Ref S2150E-100
Identity
- Device Name
- SARS-CoV-2 S-protein RBD IgG Antibody Test Kit (Chemiluminescence Immunoassay) EUDAMED
- Model / Reference
- S2150E-75 EUDAMEDS2150E-50 EUDAMEDS2150E-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792742819 EUDAMED06955792742802 EUDAMED06955792742826 EUDAMED
- Basic UDI-DI
- B-06955792742819 EUDAMEDB-06955792742802 EUDAMEDB-06955792742826 EUDAMED
- EMDN Code
- W0105040619 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
SARS-CoV-2 S-protein RBD IgG Antibody Test Kit (Chemiluminescence Immunoassay) 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-06955792742819 | 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 (3)
- EUDAMED d3402f4c-6304-4248-977d-4cbc24d8f791 61 fields · synced Jul 8, 2026
- EUDAMED 63ccb8d3-48ca-4367-a5a2-43e2bb961a16 61 fields · synced May 18, 2026
- EUDAMED f606614b-cf24-4f7e-b137-26be0ed681cb 61 fields · synced May 18, 2026