DHEA-S (eCLIA)
by Shenzhen Lifotronic Technology Co., Ltd. EUDAMED
Active
Ref 0320514901, 0320514903Model 100T, 50T
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-06978139075722 | Date22 Jul 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDD Expiring
Specification
- Model / Reference
- 100T, 0320514901, 50T, 0320514903
- Primary DI / UDI-DI
- 06978139075722, 06978139075746
- Basic UDI-DI
- B-06978139075722, B-06978139075746
- EMDN Code
- W0102050102 Dehydro-epiandrosterone sulphate (incl. dhea)
- Device Class
- Class IVD General
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000005654
- Authorised representative
- Umedwings Netherlands B.V. NL-AR-000000444
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Properties
Other properties (7)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No