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AFP Assay kit CLIA
EUDAMEDClass IVD General (EU MDR)
Ref SUPM066072Ref SUPM066036
Identity
- Trade Name
- AFP Assay kit CLIA EUDAMED
- Device Name
- AFP Assay kit CLIA EUDAMED
- Model / Reference
- SUPM066072 EUDAMEDSUPM066036 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974521001003 EUDAMED06974521000990 EUDAMED
- Basic UDI-DI
- B-06974521001003 EUDAMEDB-06974521000990 EUDAMED
- EMDN Code
- W0102039001 ALPHAFETOPROTEIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
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
AFP Assay kit CLIA by Shenzhen Superbio Technology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06974521001003 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Superbio Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000024149
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (2)
- EUDAMED f054696c-1fb5-4370-b405-6a9b72e8696a 61 fields · synced Jul 9, 2026
- EUDAMED d2d23555-5ced-465f-be29-d3858c473a99 61 fields · synced May 19, 2026