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DHEA-S (eCLIA)
EUDAMEDClass IVD General (EU MDR)
Ref 0320514904Model 2×100TRef 0320514903Model 100TRef 0320514901Model 50TRef 0320514902Model 2×50T
Identity
- Trade Name
- DHEA-S (eCLIA) EUDAMED
- Device Name
- DHEA-S (eCLIA) EUDAMED
- Model / Reference
- 2×100T EUDAMED0320514904 EUDAMED100T EUDAMED0320514903 EUDAMED50T EUDAMED0320514901 EUDAMED2×50T EUDAMED0320514902 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978139075685 EUDAMED06978139075722 EUDAMED06978139075746 EUDAMED06978139075739 EUDAMED
- Basic UDI-DI
- B-06978139075685 EUDAMEDB-06978139075722 EUDAMEDB-06978139075746 EUDAMEDB-06978139075739 EUDAMED
- EMDN Code
- W0102050102 DEHYDRO-EPIANDROSTERONE SULPHATE (INCL. DHEA) 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
DHEA-S (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-06978139075685 | 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 (4)
- EUDAMED ca8ed12c-8619-4bca-ab52-47552475bbfb 61 fields · synced Jul 17, 2026
- EUDAMED cc957349-2293-4949-8704-6d1aa7ecf551 61 fields · synced May 17, 2026
- EUDAMED 52775130-5d6d-47ec-ac51-f9d7a45af5b9 61 fields · synced May 17, 2026
- EUDAMED 7d385409-3d56-4ab5-914e-de7490870c7f 61 fields · synced May 18, 2026