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Cortisol (eCLIA)
EUDAMEDClass IVD General (EU MDR)
Ref 0320510303Model 100TRef 0320510302Model 2×50TRef 0320510304Model 2×100T
Identity
- Trade Name
- Cortisol (eCLIA) EUDAMED
- Device Name
- Cortisol (eCLIA) EUDAMED
- Model / Reference
- 100T EUDAMED0320510303 EUDAMED2×50T EUDAMED0320510302 EUDAMED2×100T EUDAMED0320510304 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975984062884 EUDAMED06975984064253 EUDAMED06975984064260 EUDAMED
- Basic UDI-DI
- B-06975984062884 EUDAMEDB-06975984064253 EUDAMEDB-06975984064260 EUDAMED
- EMDN Code
- W0102060203 CORTISOL EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
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
Cortisol (eCLIA) by Shenzhen Lifotronic Technology Co., Ltd. — 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-06975984062884 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Lifotronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005654
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (3)
- EUDAMED 42da3fa7-9a63-44bc-9ddc-ce299fe766d8 61 fields · synced Jul 31, 2026
- EUDAMED d954a3cc-a0b1-4c2e-a402-5952949e4d1b 61 fields · synced May 18, 2026
- EUDAMED d69c15a2-bf66-4c82-9e64-f045b8516705 61 fields · synced May 18, 2026