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Carbohydrate Antigen 15-3 Quantitative Diagnostic Kit (CLIA)
EUDAMEDClass IVD General (EU MDR)
Ref DR-CLIA-CM-B006Model 250 tests/kitRef DR-CLIA-CM-A006Model 100 tests/kit
Identity
- Device Name
- Carbohydrate Antigen 15-3 Quantitative Diagnostic Kit (CLIA) EUDAMED
- Model / Reference
- 250 tests/kit EUDAMEDDR-CLIA-CM-B006 EUDAMED100 tests/kit EUDAMEDDR-CLIA-CM-A006 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974671100434 EUDAMED06974671100427 EUDAMED
- Basic UDI-DI
- B-06974671100434 EUDAMEDB-06974671100427 EUDAMED
- EMDN Code
- W0102030102 CANCER ANTIGEN 15-3 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Greece 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
Carbohydrate Antigen 15-3 Quantitative Diagnostic Kit (CLIA) by Darui Biotechnology 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-06974671100434 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Darui Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000030310
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED b46d8687-571b-4293-a3ab-1843f5d0c91a 61 fields · synced Jul 28, 2026
- EUDAMED d5fdb313-e523-45af-af59-54e4f9d9d0c4 61 fields · synced May 18, 2026