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H. pylori Antibody Rapid Test
EUDAMEDClass B (EU MDR)
Ref Format (cassette): A4A411;Format (strip): A4A410Model Format (cassette): A4A411125, A4A411140, A4A411225, A4A411240 Format (strip): A4A410150, A4A410250
Identity
- Trade Name
- H. pylori Antibody Rapid Test EUDAMED
- Device Name
- H. pylori Antibody Rapid Test EUDAMED
- Model / Reference
- Format (cassette): A4A411125, A4A411140, A4A411225, A4A411240 Format (strip): A4A410150, A4A410250 EUDAMEDFormat (cassette): A4A411;Format (strip): A4A410 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952804831967 EUDAMED
- Basic UDI-DI
- 69528048A4A41105L EUDAMED
- EMDN Code
- W0105010402 H. PYLORI ANTIBODY ASSAYS EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Spain 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
New Device
No
EUDAMED
H. pylori Antibody Rapid Test by Assure Tech. (hangzhou) Co., Ltd. — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 69528048A4A41105L | Class B | Active |
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Manufacturer
- Manufacturer
- Assure Tech. (Hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000002170
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED f5c1cc2e-35ac-480b-9540-238bf209c099 61 fields · synced Jun 18, 2026
- EUDAMED f5c1cc2e-35ac-480b-9540-238bf209c099-1 61 fields · synced Jun 10, 2026