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Estradiol Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref S2016E-200Ref S2016E-75Ref S2016E-150Ref S2016E-50
Identity
- Device Name
- Estradiol Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2016E-200 EUDAMEDS2016E-75 EUDAMEDS2016E-150 EUDAMEDS2016E-50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792737235 EUDAMED06955792737204 EUDAMED06955792737228 EUDAMED06955792737198 EUDAMED
- Basic UDI-DI
- B-06955792737235 EUDAMEDB-06955792737204 EUDAMEDB-06955792737228 EUDAMEDB-06955792737198 EUDAMED
- EMDN Code
- W0102050103 ESTRADIOL 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
Estradiol 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-06955792737235 | 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 8e204988-9c03-400d-83ae-1fa278b35feb 61 fields · synced Jul 20, 2026
- EUDAMED aea71593-56ec-40be-bbe8-8800086532c3 61 fields · synced May 18, 2026
- EUDAMED 8e233bc8-72bc-457e-9540-416838ce4370 61 fields · synced May 18, 2026
- EUDAMED e34aba4b-a1c7-4af2-bd5c-07b85013845b 61 fields · synced May 19, 2026