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H. pylori Antigen Rapid Test
EUDAMEDClass B (EU MDR)
Ref A4A412Model A4A412125,A4A412225
Identity
- Trade Name
- H. pylori Antigen Rapid Test EUDAMED
- Device Name
- H. pylori Antigen Rapid Test EUDAMED
- Model / Reference
- A4A412125,A4A412225 EUDAMEDA4A412 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952804810641 EUDAMED
- Basic UDI-DI
- 69528048A4A41205P EUDAMED
- EMDN Code
- W0105010401 H. PYLORI ANTIGEN DETECTION 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 Antigen 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 | 69528048A4A41205P | 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 (1)
- EUDAMED 238519e7-89b1-46cf-89d9-b5523068e9c7 61 fields · synced Jun 19, 2026