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Helicobacter Pylori (HP) Urease Antibody Detection Kit
EUDAMEDClass IVD General (EU MDR)
Ref P2201025
Identity
- Trade Name
- Helicobacter Pylori (HP) Urease Antibody Detection Kit EUDAMED
- Device Name
- Helicobacter Pylori (HP) Urease Antibody Detection Kit EUDAMED
- Model / Reference
- P2201025 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974854620582 EUDAMED
- Basic UDI-DI
- B-06974854620582 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 (HP) Urease Antibody Detection Kit by Beijing Jinwofu Bioengineering Technology 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-06974854620582 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Beijing Jinwofu Bioengineering Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000035739
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 862c3c64-d228-488c-94e9-9b8fdb43d6aa 61 fields · synced Aug 2, 2026