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Carbohydrate Antigen 19-9 (eCLIA)
EUDAMEDClass IVD General (EU MDR)
Ref 0320500803Model 100 TModel 50T, 2×50T, 100T ,2×100T
Identity
- Trade Name
- Carbohydrate Antigen 19-9 (eCLIA) EUDAMEDCarbonhydrate Antigen 19-9 (eCLIA) EUDAMED
- Device Name
- Carbohydrate Antigen 19-9 (eCLIA) EUDAMEDCarbonhydrate Antigen 19-9 (eCLIA) EUDAMED
- Model / Reference
- 100 T EUDAMED0320500803 EUDAMED50T, 2×50T, 100T ,2×100T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970341685812 EUDAMED
- Basic UDI-DI
- B-06970341685812 EUDAMED69703416803205024J9 EUDAMED
- EMDN Code
- W0102030103 CANCER ANTIGEN 19-9 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass C EUDAMED
- Market of Registration
- Germany 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
Carbohydrate Antigen 19-9 (eCLIA) by Shenzhen Lifotronic Technology Co., Ltd. — Class IVD General — IVDR, IVDD — listed in EUDAMED
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-06970341685812 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06970341685812 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Lifotronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005654
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED c417d29f-8053-4b38-b5f0-d739a3590db6 61 fields · synced Jul 12, 2026
- EUDAMED 3a96548b-3666-402f-a132-adc144a378aa 61 fields · synced May 17, 2026