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CA50 (eCLIA)
EUDAMEDClass IVD General (EU MDR)
Ref 0320509401Model 50TModel 50T, 2×50T, 100T, 2×100T
Identity
- Trade Name
- CA50 (eCLIA) EUDAMED
- Device Name
- CA50 (eCLIA) EUDAMED
- Model / Reference
- 50T EUDAMED0320509401 EUDAMED50T, 2×50T, 100T, 2×100T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975984064352 EUDAMED
- Basic UDI-DI
- B-06975984064352 EUDAMED69703416803205087JZ EUDAMED
- EMDN Code
- W0102030104 CANCER ANTIGEN 50 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass C EUDAMED
- Market of Registration
- Netherlands EUDAMEDGermany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
New Device
No
EUDAMED
CA50 (eCLIA) by Shenzhen Lifotronic Technology Co., Ltd. — Class IVD General — IVDR, IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-06975984064352 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06975984064352 | 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 (2)
- EUDAMED ef71a918-f129-43f1-a15a-b69a87e04339 61 fields · synced Jul 19, 2026
- EUDAMED 43b36207-b670-4772-8147-00a19ebcf726 61 fields · synced May 19, 2026