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Cancer Antigen 50 Detection Kit (Chemiluminescence Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 3014822Model 2×50 Tests/kitRef 3010682Model 1×50 Tests/kit
Identity
- Trade Name
- Cancer Antigen 50 Detection Kit (Chemiluminescence Immunoassay) EUDAMED
- Device Name
- Cancer Antigen 50 Detection Kit (Chemiluminescence Immunoassay) EUDAMED
- Model / Reference
- 2×50 Tests/kit EUDAMED3014822 EUDAMED1×50 Tests/kit EUDAMED3010682 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202224300 EUDAMED06925794520982 EUDAMED
- Basic UDI-DI
- B-06942202224300 EUDAMEDB-06925794520982 EUDAMED
- EMDN Code
- W0102030104 CANCER ANTIGEN 50 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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
Cancer Antigen 50 Detection Kit (Chemiluminescence Immunoassay) by Dirui Industrial Co., Ltd — Class IVD General — IVDD — listed in EUDAMED
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-06942202224300 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 2329dc7c-c3ed-464f-bac9-f5bc59125a1a 61 fields · synced Jul 9, 2026
- EUDAMED 172b2f66-2860-40e3-a424-29ccd52f8398 61 fields · synced May 18, 2026