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Inhibin B Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref S2029E-50Ref S2029E-75Ref S2029E-150Ref S2029E-25Ref S2029E-200Ref S2029E-100
Identity
- Device Name
- Inhibin B Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2029E-50 EUDAMEDS2029E-75 EUDAMEDS2029E-150 EUDAMEDS2029E-25 EUDAMEDS2029E-200 EUDAMEDS2029E-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792738577 EUDAMED06955792738584 EUDAMED06955792738607 EUDAMED06955792738560 EUDAMED06955792738614 EUDAMED06955792738591 EUDAMED
- Basic UDI-DI
- B-06955792738577 EUDAMEDB-06955792738584 EUDAMEDB-06955792738607 EUDAMEDB-06955792738560 EUDAMEDB-06955792738614 EUDAMEDB-06955792738591 EUDAMED
- EMDN Code
- W0102050214 INHIBIN A/B (PRENATAL SCREENING) 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
Inhibin B 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-06955792738577 | 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 (6)
- EUDAMED cdd87078-0912-464f-92c5-891a64439b9a 61 fields · synced Jul 30, 2026
- EUDAMED d1ef44ba-158d-41bb-925c-df33a86e8fcc 61 fields · synced May 17, 2026
- EUDAMED fca61923-550d-4cba-9d86-b5038ab39f39 61 fields · synced May 17, 2026
- EUDAMED a94fda6c-a402-451b-a8b0-d58f6d72921b 61 fields · synced May 18, 2026
- EUDAMED 972205c1-a669-4080-a1ac-0be7dedcb619 61 fields · synced May 18, 2026
- EUDAMED ebe0bd77-bf94-4370-81eb-bb0ba639cac9 61 fields · synced May 18, 2026