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Helicobacter pylori (HP) rapid urease test card (biochemical method)
EUDAMEDClass IVD General (EU MDR)
Ref 5 tests/ kit
Identity
- Device Name
- Helicobacter pylori (HP) rapid urease test card (biochemical method) EUDAMED
- Model / Reference
- 5 tests/ kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975491761195 EUDAMED
- Basic UDI-DI
- B-06975491761195 EUDAMED
- EMDN Code
- W0105010499 H. PYLORI REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria 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) rapid urease test card (biochemical method) by Shenzhen Sciarray Biotech 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-06975491761195 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Sciarray Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000038307
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED c1c93f25-7381-4fa7-b198-2851c38b4f30 61 fields · synced Jun 18, 2026