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H. pylori Antigen Rapid Test
EUDAMEDClass IVD General (EU MDR)
Ref 1 Test/KitRef 2 Tests/KitRef 20 Tests/KitRef 40 Tests/Kit
Identity
- Device Name
- H. pylori Antigen Rapid Test EUDAMED
- Model / Reference
- 1 Test/Kit EUDAMED2 Tests/Kit EUDAMED20 Tests/Kit EUDAMED40 Tests/Kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975166204385 EUDAMED06975166204392 EUDAMED06975166204415 EUDAMED06975166204422 EUDAMED
- Basic UDI-DI
- B-06975166204385 EUDAMEDB-06975166204392 EUDAMEDB-06975166204415 EUDAMEDB-06975166204422 EUDAMED
- EMDN Code
- W0101060199 BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER EUDAMEDW0105090102 H. PYLORI - RT & POC 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
H. pylori Antigen Rapid Test by Avioq Bio-tech Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06975166204385 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Avioq Bio-tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000048146
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (5)
- EUDAMED d5e8683d-b9c6-4ecb-ad97-7bfed5f46b2d 61 fields · synced Jul 26, 2026
- EUDAMED be449685-9d88-41d1-9690-f1a5d273c5c9 61 fields · synced Jul 13, 2026
- EUDAMED 10f11aec-8111-4ce8-ba39-459b427630fd 61 fields · synced Jul 13, 2026
- EUDAMED df9cb198-fd0a-409f-b3b7-7de5b3d2d664 61 fields · synced Jul 18, 2026
- EUDAMED 4717e982-445b-4ea5-b765-63826bd6665d 61 fields · synced Jul 26, 2026