← Back to catalogue
Alpha-Fetoprotein Quantitative Diagnostic Kit (CLIA)
EUDAMEDClass IVD General (EU MDR)
Ref DR-CLIA-CM-B001Model 250 tests/kitRef DR-CLIA-CM-A001Model 100 tests/kit
Identity
- Device Name
- Alpha-Fetoprotein Quantitative Diagnostic Kit (CLIA) EUDAMED
- Model / Reference
- 250 tests/kit EUDAMEDDR-CLIA-CM-B001 EUDAMED100 tests/kit EUDAMEDDR-CLIA-CM-A001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974671100397 EUDAMED06974671100380 EUDAMED
- Basic UDI-DI
- B-06974671100397 EUDAMEDB-06974671100380 EUDAMED
- EMDN Code
- W0102039001 ALPHAFETOPROTEIN 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
Alpha-Fetoprotein 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-06974671100397 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Darui Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000030310
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED bc65640b-e69b-42fb-91f7-9edf7fba3afa 61 fields · synced Jul 10, 2026
- EUDAMED 2dd3b40b-d6ef-4956-abe3-16db3e6cc5ff 61 fields · synced May 18, 2026