EPO (eCLIA)
by Shenzhen Lifotronic Technology Co., Ltd. China EUDAMED
Ref 0320515001Model 50T
EMDN W0102070101
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | NumberB-06978139078204 | Date30 Apr 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Model / Reference
- 50T, 0320515001
- Primary DI / UDI-DI
- 06978139078204
- Basic UDI-DI
- B-06978139078204
- EMDN Code
- W0102070101 Erythropoietin
- 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 & raw data
Show properties, registry sources and raw records
Other properties (7)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
Sources (1)
- EUDAMED aa3fd4a7-d83d-4c52-9ee4-14324b9a32c1