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KEYU H. Pylori Rapid Test Kit (Colloidal gold method)
EUDAMEDClass IVD General (EU MDR)
Ref HP-III
Identity
- Trade Name
- KEYU H. Pylori Rapid Test Kit (Colloidal gold method) EUDAMED
- Device Name
- H. Pylori Rapid Test Kit (Colloidal gold method) EUDAMED
- Model / Reference
- HP-III EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974735360644 EUDAMED
- Basic UDI-DI
- B-06974735360644 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
Yes
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
KEYU H. Pylori Rapid Test Kit (Colloidal gold method) by Zhuhai Keyu Biological Engineering 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-06974735360644 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Zhuhai Keyu Biological Engineering Co., Ltd
- EUDAMED SRN
- CN-MF-000023195
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED dc7db2fc-3d6a-4263-b2f7-82fdaf5eb2df 61 fields · synced Jun 19, 2026