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Interleukin-1β Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref S2033E-50Ref S2033E-200Ref S2033E-75
Identity
- Device Name
- Interleukin-1β Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2033E-50 EUDAMEDS2033E-200 EUDAMEDS2033E-75 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792738812 EUDAMED06955792738850 EUDAMED06955792738829 EUDAMED
- Basic UDI-DI
- B-06955792738812 EUDAMEDB-06955792738850 EUDAMEDB-06955792738829 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-1β 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-06955792738812 | 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 065e2a0f-5642-461b-b29e-14dbc66fe6e8 61 fields · synced Jul 16, 2026
- EUDAMED 38b834a8-0f3d-4dbf-b449-78ab142ee3d0 61 fields · synced May 17, 2026
- EUDAMED 6dee7850-6735-429d-9bc5-c91082692bd5 61 fields · synced May 18, 2026