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ANA Assay Kit (Fluorescence Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref DL233907Model 50tests/kitRef 20T
Identity
- Trade Name
- ANA Assay Kit (Fluorescence Immunoassay) EUDAMED
- Device Name
- ANA Assay Kit (Fluorescence Immunoassay) EUDAMED
- Model / Reference
- 50tests/kit EUDAMEDDL233907 EUDAMED20T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975424223882 EUDAMED06975424221789 EUDAMED
- Basic UDI-DI
- B-06975424223882 EUDAMEDB-06975424221789 EUDAMED
- EMDN Code
- W0102100101 ANA SCREENING EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria 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
ANA Assay Kit (Fluorescence Immunoassay) by DiYaLab ZJG Biotech 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-06975424223882 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- DiYaLab ZJG Biotech Co., Ltd
- EUDAMED SRN
- CN-MF-000048648
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 946064ce-d8c8-4c48-b62e-99eb88efd6ee 61 fields · synced Oct 6, 2026
- EUDAMED efa34fee-29bb-4d2f-8e41-5be102ee8b0b 61 fields · synced May 17, 2026