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Interleukin-10 Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref S2037E-75Ref S2037E-100Ref S2037E-50Ref S2037E-25
Identity
- Device Name
- Interleukin-10 Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2037E-75 EUDAMEDS2037E-100 EUDAMEDS2037E-50 EUDAMEDS2037E-25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792739062 EUDAMED06955792739079 EUDAMED06955792739055 EUDAMED06955792739048 EUDAMED
- Basic UDI-DI
- B-06955792739062 EUDAMEDB-06955792739079 EUDAMEDB-06955792739055 EUDAMEDB-06955792739048 EUDAMED
- EMDN Code
- W01030606 OTHER INTERLEUKINS (EXCEPT FOR IL-6) 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
Interleukin-10 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-06955792739062 | 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 146689e3-9cc9-4649-a870-393cf35f13f0 61 fields · synced Jul 21, 2026
- EUDAMED e18a1ab9-3ce5-4fc2-a08b-71882eeab72d 61 fields · synced May 16, 2026
- EUDAMED dcd3d7d5-0b7e-4eba-99b6-d0797073129a 61 fields · synced May 16, 2026
- EUDAMED 6efb9520-b1b2-45b5-9b5e-a4a203f90d85 61 fields · synced May 17, 2026