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Helicobacter Pylori Antibody (HP) Assay Kit (Latex-enhanced Immunoturbidimetric…
EUDAMEDClass IVD General (EU MDR)
Ref 131H150TSCRef 131H50TSC
Identity
- Trade Name
- Helicobacter Pylori Antibody (HP) Assay Kit (Latex-enhanced Immunoturbidimetric Method) EUDAMED
- Device Name
- Helicobacter Pylori Antibody (HP) Assay Kit (Latex-enhanced Immunoturbidimetric Method) EUDAMED
- Model / Reference
- 131H150TSC EUDAMED131H50TSC EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-131H150TSCJE EUDAMEDD-131H50TSC2Q EUDAMED
- Basic UDI-DI
- B-131H150TSCJE EUDAMEDB-131H50TSC2Q EUDAMED
- EMDN Code
- W0105010402 H. PYLORI ANTIBODY ASSAYS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain 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 Antibody (HP) Assay Kit (Latex-enhanced Immunoturbidimetric… by Yhlo Biotech (nanjing) Co., Ltd. — Class IVD General — IVDD — listed in…
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-131H150TSCJE | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Yhlo Biotech (nanjing) Co., Ltd.
- EUDAMED SRN
- CN-MF-000050474
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (2)
- EUDAMED 83066803-2cf3-4c31-af68-2a9440631284 61 fields · synced Jul 24, 2026
- EUDAMED 1667a1cd-90c0-4b6c-8eda-32a778c2f098 61 fields · synced May 19, 2026