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Cortisol CLIA Microparticles
EUDAMEDClass C (EU MDR)
Ref CMD0302Model AutuLumo AnalyzerRef CMD0301Ref CMD0304
Identity
- Trade Name
- Cortisol CLIA Microparticles EUDAMED
- Model / Reference
- AutuLumo Analyzer EUDAMEDCMD0302 EUDAMEDCMD0301 EUDAMEDCMD0304 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970150908522 EUDAMED06970150906153 EUDAMED06970150906177 EUDAMED
- Basic UDI-DI
- 697015090000020GN EUDAMED
- EMDN Code
- W0102060203 CORTISOL EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Italy EUDAMEDSlovenia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
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
New Device
No
EUDAMED
Cortisol CLIA Microparticles by Autobio Diagnostics Co., Ltd. — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697015090000020GN | Class C | Active |
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Manufacturer
- Manufacturer
- Autobio Diagnostics Co., Ltd.
- EUDAMED SRN
- CN-MF-000003348
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (3)
- EUDAMED b289033d-a173-493b-861d-61cb1c02e34d 61 fields · synced Aug 3, 2026
- EUDAMED 73e0a757-2663-4964-b627-a5fdbbc67a43 61 fields · synced May 17, 2026
- EUDAMED d931f354-e07f-47e7-bdf9-c75a14969e27 61 fields · synced May 17, 2026