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Interleukin-2 Receptor Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref S2034E-100Ref S2034E-150Ref S2034E-50Ref S2034E-200Ref S2034E-75
Identity
- Device Name
- Interleukin-2 Receptor Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2034E-100 EUDAMEDS2034E-150 EUDAMEDS2034E-50 EUDAMEDS2034E-200 EUDAMEDS2034E-75 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792738898 EUDAMED06955792738904 EUDAMED06955792738874 EUDAMED06955792738911 EUDAMED06955792738881 EUDAMED
- Basic UDI-DI
- B-06955792738898 EUDAMEDB-06955792738904 EUDAMEDB-06955792738874 EUDAMEDB-06955792738911 EUDAMEDB-06955792738881 EUDAMED
- EMDN Code
- W01030607 INTERLEUKINS RECEPTORS (IL-2R,IL6R ...) 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-2 Receptor 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-06955792738898 | 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 (5)
- EUDAMED bcebfc42-d489-4bac-aea2-c15325162be3 61 fields · synced Aug 3, 2026
- EUDAMED 087defc9-0e2e-4a82-af78-17d9b3c8e2ae 61 fields · synced May 17, 2026
- EUDAMED 52fdf470-28eb-4aef-b3a2-a5c5fb4c0949 61 fields · synced May 17, 2026
- EUDAMED cd1487b3-55e4-4e00-9723-ec5bc7abc90c 61 fields · synced May 17, 2026
- EUDAMED ca7861fd-2bbf-4a37-b8df-4e457ba4b68c 61 fields · synced May 18, 2026