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EPO (eCLIA)
EUDAMEDClass IVD General (EU MDR)
Ref 0320515004Model 2×100TRef 0320515002Model 2×50TRef 0320515001Model 50T
Identity
- Trade Name
- EPO (eCLIA) EUDAMED
- Device Name
- EPO (eCLIA) EUDAMED
- Model / Reference
- 2×100T EUDAMED0320515004 EUDAMED2×50T EUDAMED0320515002 EUDAMED50T EUDAMED0320515001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978139078228 EUDAMED06978139078235 EUDAMED06978139078204 EUDAMED
- Basic UDI-DI
- B-06978139078228 EUDAMEDB-06978139078235 EUDAMEDB-06978139078204 EUDAMED
- EMDN Code
- W0102070101 ERYTHROPOIETIN 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
EPO (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-06978139078228 | 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 1cc1db68-d30a-4827-aeaa-1817adf5b2b6 61 fields · synced Jul 26, 2026
- EUDAMED f8bcab7f-a21e-49e3-8b86-eab461518094 61 fields · synced May 17, 2026
- EUDAMED aa3fd4a7-d83d-4c52-9ee4-14324b9a32c1 61 fields · synced May 18, 2026