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Soluble Growth Stimulation Expressed Gene 2 Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref S2058E-75Ref S2058E-50Ref S2058E-25Ref S2058E-150Ref S2058E-200
Identity
- Device Name
- Soluble Growth Stimulation Expressed Gene 2 Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2058E-75 EUDAMEDS2058E-50 EUDAMEDS2058E-25 EUDAMEDS2058E-150 EUDAMEDS2058E-200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792740280 EUDAMED06955792740273 EUDAMED06955792740266 EUDAMED06955792740303 EUDAMED06955792740310 EUDAMED
- Basic UDI-DI
- B-06955792740280 EUDAMEDB-06955792740273 EUDAMEDB-06955792740266 EUDAMEDB-06955792740303 EUDAMEDB-06955792740310 EUDAMED
- EMDN Code
- W01021314 ST2 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
Soluble Growth Stimulation Expressed Gene 2 Chemiluminescence Immunoassay Kit by Sansure Biotech Inc. — Class IVD General — IVDD — listed in EUDAMED
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-06955792740280 | 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 f643ad93-94ee-4cf9-9125-552e6c877a3e 61 fields · synced Aug 4, 2026
- EUDAMED 6df14021-1ad2-4cb2-a79a-c0b226ca1328 61 fields · synced May 16, 2026
- EUDAMED 6e6f7617-b6c3-4cc2-ba23-2d57d6710fe0 61 fields · synced May 17, 2026
- EUDAMED d3bb7812-d57f-432b-94c7-3ec28be3f01f 61 fields · synced May 18, 2026
- EUDAMED 4f67b54f-0e18-4a4f-9abd-78a05a2c8603 61 fields · synced May 18, 2026