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Cortisol Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref S2135E-150Ref S2135E-50Ref S2135E-200
Identity
- Device Name
- Cortisol Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2135E-150 EUDAMEDS2135E-50 EUDAMEDS2135E-200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792741942 EUDAMED06955792741911 EUDAMED06955792741959 EUDAMED
- Basic UDI-DI
- B-06955792741942 EUDAMEDB-06955792741911 EUDAMEDB-06955792741959 EUDAMED
- EMDN Code
- W0102060203 CORTISOL 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
Cortisol 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-06955792741942 | 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 (3)
- EUDAMED 8078bdda-b672-4446-a885-3fd75eab8497 61 fields · synced Jul 24, 2026
- EUDAMED 61ae1585-6860-4731-81db-cf330f2bf8fa 61 fields · synced May 17, 2026
- EUDAMED c3e14390-90d8-492b-b18d-b71690b614e6 61 fields · synced May 19, 2026