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Carbohydrate Antigen 19-9 Quantitative Diagnostic Kit (CLIA)
EUDAMEDClass IVD General (EU MDR)
Ref DR-CLIA-CM-B009Model 250 tests/kitRef DR-CLIA-CM-A009Model 100 tests/kit
Identity
- Device Name
- Carbohydrate Antigen 19-9 Quantitative Diagnostic Kit (CLIA) EUDAMED
- Model / Reference
- 250 tests/kit EUDAMEDDR-CLIA-CM-B009 EUDAMED100 tests/kit EUDAMEDDR-CLIA-CM-A009 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974671100472 EUDAMED06974671100465 EUDAMED
- Basic UDI-DI
- B-06974671100472 EUDAMEDB-06974671100465 EUDAMED
- EMDN Code
- W0102030103 CANCER ANTIGEN 19-9 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 19-9 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-06974671100472 | 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 4b7b02ea-0acd-49d8-9ad2-39a2d2b1660e 61 fields · synced Jul 28, 2026
- EUDAMED bb2cccbe-3623-49a5-9ff9-a80c5ed59be7 61 fields · synced May 18, 2026