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Progesterone Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref S2051E-50Ref S2051E-100
Identity
- Device Name
- Progesterone Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2051E-50 EUDAMEDS2051E-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792739895 EUDAMED06955792739918 EUDAMED
- Basic UDI-DI
- B-06955792739895 EUDAMEDB-06955792739918 EUDAMED
- EMDN Code
- W0102050106 PROGESTERONE 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
Progesterone 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-06955792739895 | 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 (2)
- EUDAMED dea5fef3-e590-4081-84bb-834bf5e3eecb 61 fields · synced Jul 15, 2026
- EUDAMED b0644f8d-41fa-4c26-a174-49f501d3f43e 61 fields · synced May 17, 2026