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Sex Hormone-binding Globulin Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref S2152E-75Ref S2152E-200Ref S2152E-50Ref S2152E-100Ref S2152E-25
Identity
- Device Name
- Sex Hormone-binding Globulin Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2152E-75 EUDAMEDS2152E-200 EUDAMEDS2152E-50 EUDAMEDS2152E-100 EUDAMEDS2152E-25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792742925 EUDAMED06955792742956 EUDAMED06955792742918 EUDAMED06955792742932 EUDAMED06955792742901 EUDAMED
- Basic UDI-DI
- B-06955792742925 EUDAMEDB-06955792742956 EUDAMEDB-06955792742918 EUDAMEDB-06955792742932 EUDAMEDB-06955792742901 EUDAMED
- EMDN Code
- W0102050109 SEX HORMONE BINDING GLOBULIN 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
Sex Hormone-binding Globulin 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-06955792742925 | 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 972964a5-af48-40df-a2ba-a8195795cdc6 61 fields · synced Oct 5, 2026
- EUDAMED 915f15f3-5208-4a32-ac32-c69ee1f38214 61 fields · synced May 16, 2026
- EUDAMED 7db3899a-9412-48f4-bd49-c246a306b2ad 61 fields · synced May 17, 2026
- EUDAMED 18259f5c-44ce-4bd1-90a2-8f89621094d5 61 fields · synced May 17, 2026
- EUDAMED 71be8927-1f63-49bf-9c75-783cfcde95d9 61 fields · synced May 19, 2026