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Helicobacter pylori (HP) rapid urease test card (biochemical method)
EUDAMEDClass IVD General (EU MDR)
Ref 80 tests/ kitRef 1 test/ kitRef 3 tests/ kitRef 20 tests/ kit
Identity
- Device Name
- Helicobacter pylori (HP) rapid urease test card (biochemical method) EUDAMED
- Model / Reference
- 80 tests/ kit EUDAMED1 test/ kit EUDAMED3 tests/ kit EUDAMED20 tests/ kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975491761232 EUDAMED06975491761164 EUDAMED06975491761188 EUDAMED06975491761218 EUDAMED
- Basic UDI-DI
- B-06975491761232 EUDAMEDB-06975491761164 EUDAMEDB-06975491761188 EUDAMEDB-06975491761218 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-06975491761232 | 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 (4)
- EUDAMED 58287d3e-d7ec-447e-838c-ceb7954b85fe 61 fields · synced Oct 6, 2026
- EUDAMED c23144d6-3178-4cdf-b15b-4097f3643b08 61 fields · synced May 11, 2026
- EUDAMED 72873c24-1181-4df6-b299-fd963c22761e 61 fields · synced May 16, 2026
- EUDAMED 2308a16d-a7eb-4fef-9841-c8b97b8c8350 61 fields · synced May 17, 2026