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Helicobacter Pylori Antigen Test（Fluorescence Immunoassay）
EUDAMEDClass IVD General (EU MDR)
Ref DL247102Model 50tests/kit
Identity
- Device Name
- Helicobacter Pylori Antigen Test（Fluorescence Immunoassay） EUDAMED
- Model / Reference
- 50tests/kit EUDAMEDDL247102 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975424225077 EUDAMED
- Basic UDI-DI
- B-06975424225077 EUDAMED
- EMDN Code
- W0105010499 H. PYLORI REAGENTS - OTHER 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
Helicobacter Pylori Antigen Test（Fluorescence Immunoassay） by DiYaLab ZJG Biotech 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-06975424225077 | 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 (1)
- EUDAMED 8d878605-100c-4cde-af67-4870da5077d8 61 fields · synced Jul 19, 2026