← Back to catalogue
CA242 (eCLIA)
EUDAMEDClass IVD General (EU MDR)
Ref 0320510701Model 50TRef 0320510704Model 2×100TRef 0320510702Model 2×50T
Identity
- Trade Name
- CA242 (eCLIA) EUDAMED
- Device Name
- CA242 (eCLIA) EUDAMED
- Model / Reference
- 50T EUDAMED0320510701 EUDAMED2×100T EUDAMED0320510704 EUDAMED2×50T EUDAMED0320510702 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975984064314 EUDAMED06975984064345 EUDAMED06975984064321 EUDAMED
- Basic UDI-DI
- B-06975984064314 EUDAMEDB-06975984064345 EUDAMEDB-06975984064321 EUDAMED
- EMDN Code
- W0102030108 CANCER ANTIGEN 242 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMEDEUDAMED
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
CA242 (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-06975984064314 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Lifotronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005654
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (3)
- EUDAMED 2824da07-3323-43e4-a0d0-dd8679ef2f32 61 fields · synced Jul 29, 2026
- EUDAMED 1f3b3f2a-5ba9-4a9c-a4f5-5c8dfee62265 61 fields · synced May 16, 2026
- EUDAMED 89168486-4fb5-43dd-996c-9e339d45988d 61 fields · synced May 16, 2026