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Helicobacter Pylori Antigen (HP) Test Kit (Colloidal Gold)
EUDAMEDClass IVD General (EU MDR)
Ref BB1003Model 100pcs/box
Identity
- Trade Name
- Helicobacter Pylori Antigen (HP) Test Kit (Colloidal Gold) EUDAMED
- Device Name
- Helicobacter Pylori Antigen (HP) Test Kit (Colloidal Gold) EUDAMED
- Model / Reference
- 100pcs/box EUDAMEDBB1003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970522646151 EUDAMED
- Basic UDI-DI
- B-06970522646151 EUDAMED
- EMDN Code
- W0101060399 FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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
Helicobacter Pylori Antigen (HP) Test Kit (Colloidal Gold) by Sichuan Orienter Biotechnology 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-06970522646151 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Sichuan Orienter Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000003026
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (1)
- EUDAMED 0ce6fe04-56c5-41a5-b468-5727f6dd4ff1 61 fields · synced Oct 6, 2026