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Gastric Helicobacter pylori (HP) polypeptide antigen Test kit
EUDAMEDClass IVD General (EU MDR)
Ref P2201125
Identity
- Trade Name
- Gastric Helicobacter pylori (HP) polypeptide antigen Test kit EUDAMED
- Device Name
- Gastric Helicobacter pylori (HP) polypeptide antigen Test kit EUDAMED
- Model / Reference
- P2201125 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974854620599 EUDAMED
- Basic UDI-DI
- B-06974854620599 EUDAMED
- EMDN Code
- W0105010401 H. PYLORI ANTIGEN DETECTION 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
Gastric Helicobacter pylori (HP) polypeptide antigen Test kit by Beijing Jinwofu Bioengineering Technology 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-06974854620599 | 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 c811121c-26e2-4bf1-b79f-dae901ef05f2 61 fields · synced Jul 11, 2026