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Insulin Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref S2030E-75Ref S2030E-200Ref S2030E-25Ref S2030E-150Ref S2030E-100
Identity
- Device Name
- Insulin Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2030E-75 EUDAMEDS2030E-200 EUDAMEDS2030E-25 EUDAMEDS2030E-150 EUDAMEDS2030E-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792738645 EUDAMED06955792738676 EUDAMED06955792738621 EUDAMED06955792738669 EUDAMED06955792738652 EUDAMED
- Basic UDI-DI
- B-06955792738645 EUDAMEDB-06955792738676 EUDAMEDB-06955792738621 EUDAMEDB-06955792738669 EUDAMEDB-06955792738652 EUDAMED
- EMDN Code
- W0102060103 INSULIN 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
Insulin 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-06955792738645 | 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 385f8a7a-1776-4176-b8f8-afaf4fff75d9 61 fields · synced Jul 28, 2026
- EUDAMED 142ec557-7d48-40d6-a7b2-6c98aeb5e1d7 61 fields · synced May 16, 2026
- EUDAMED 27213658-addb-4c68-beb1-b9bff9969fa8 61 fields · synced May 17, 2026
- EUDAMED ca241261-9199-4aa7-9d67-2a6927099dc2 61 fields · synced May 17, 2026
- EUDAMED 131f80c6-2a01-4003-84af-7b7ce04d1537 61 fields · synced May 17, 2026