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Anti-PR3 Assay Kit(Fluorescence Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref DL234606Model 50tests/kitRef 20T
Identity
- Trade Name
- Anti-PR3 Assay Kit (Fluorescence Immunoassay) EUDAMED
- Device Name
- Anti-PR3 Assay Kit(Fluorescence Immunoassay) EUDAMEDAnti-PR3 Assay Kit (Fluorescence Immunoassay) EUDAMED
- Model / Reference
- 50tests/kit EUDAMEDDL234606 EUDAMED20T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975424223936 EUDAMED06975424221857 EUDAMED
- Basic UDI-DI
- B-06975424223936 EUDAMEDB-06975424221857 EUDAMED
- EMDN Code
- W0102100403 PR3 ANCA 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
Anti-PR3 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-06975424223936 | 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 852da37b-bd1f-4df7-a634-8dd1098d9654 61 fields · synced Oct 6, 2026
- EUDAMED f6b1715f-bf52-45fc-867a-0e923f58adc6 61 fields · synced May 19, 2026