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Interleukin-8 Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref S2036E-50Ref S2036E-75Ref S2036E-150Ref S2036E-25
Identity
- Device Name
- Interleukin-8 Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2036E-50 EUDAMEDS2036E-75 EUDAMEDS2036E-150 EUDAMEDS2036E-25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792738997 EUDAMED06955792739000 EUDAMED06955792739024 EUDAMED06955792738980 EUDAMED
- Basic UDI-DI
- B-06955792738997 EUDAMEDB-06955792739000 EUDAMEDB-06955792739024 EUDAMEDB-06955792738980 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-8 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-06955792738997 | 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 8e325d4f-15ad-45a4-8078-565eaf5cb710 61 fields · synced Aug 4, 2026
- EUDAMED a1dcd0c7-b973-45c0-8a7f-5092368b551d 61 fields · synced May 18, 2026
- EUDAMED b2c62e99-141b-47a3-a94b-15451be9e5ac 61 fields · synced May 18, 2026
- EUDAMED d5b56124-0004-4529-81f4-0a30862c961f 61 fields · synced May 18, 2026