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Alpha-fetoprotein Detection Kit (Chemiluminescence Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 3013695Model 1×50 Tests/kitRef 3013790Model 1×100 Tests/kit, 1×50 Tests/kit, 2×50 Tests/kitRef 3021043
Identity
- Trade Name
- Alpha-fetoprotein Detection Kit (Chemiluminescence Immunoassay) EUDAMED
- Device Name
- Alpha-fetoprotein Detection Kit (Chemiluminescence Immunoassay) EUDAMED
- Model / Reference
- 1×50 Tests/kit EUDAMED3013695 EUDAMED1×100 Tests/kit, 1×50 Tests/kit, 2×50 Tests/kit EUDAMED3013790 EUDAMED3021043 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794520852 EUDAMED06925794588562 EUDAMED06925794589491 EUDAMED
- Basic UDI-DI
- B-06925794520852 EUDAMED69257945W0102039001R0PV EUDAMED
- EMDN Code
- W0102039001 ALPHAFETOPROTEIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass C 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
New Device
No
EUDAMED
Alpha-fetoprotein Detection Kit (Chemiluminescence Immunoassay) by Dirui Industrial 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-06925794520852 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06925794520852 | 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 (3)
- EUDAMED 2ea1d5af-8ccf-4c32-8ff8-ceacb632c0c4 61 fields · synced Jul 17, 2026
- EUDAMED 1e06d672-b58d-4457-80cd-b5e07174fdc2 61 fields · synced May 18, 2026
- EUDAMED 814fdc47-901b-4c10-bdfe-aaafc7bf6448 61 fields · synced May 19, 2026