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SARS-CoV-2 IgM Antibody Test Kit (Chemiluminescence Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref S2055E-75Ref S2055E-50
Identity
- Device Name
- SARS-CoV-2 IgM Antibody Test Kit (Chemiluminescence Immunoassay) EUDAMED
- Model / Reference
- S2055E-75 EUDAMEDS2055E-50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792740112 EUDAMED06955792740105 EUDAMED
- Basic UDI-DI
- B-06955792740112 EUDAMEDB-06955792740105 EUDAMED
- EMDN Code
- W0102010107 IMMUNOGLOBULIN M 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 IgM 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-06955792740112 | 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 fbd2d330-60e3-45c9-b3e6-32eeafda3ef9 61 fields · synced Sep 18, 2026
- EUDAMED e21b3b38-f568-48a1-bde9-1700e9cd58cd 61 fields · synced May 19, 2026