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H.Pylori Antigen Test Kit
EUDAMEDClass C (EU MDR)
Ref HPAg4FEST-5Model Cassette Tube Strip
Identity
- Trade Name
- H.Pylori Antigen Test Kit EUDAMED
- Device Name
- H.Pylori Antigen Test Kit EUDAMED
- Model / Reference
- Cassette Tube Strip EUDAMEDHPAg4FEST-5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952062711711 EUDAMED
- Basic UDI-DI
- 69520627J016LB EUDAMED
- Unit of Use DI
- 06952062713432 EUDAMED
- EMDN Code
- W0105090102 H. PYLORI - RT & POC EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
H.Pylori Antigen Test Kit by Anhui Deepblue Medical Technology Co., Ltd — Class C — 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 | 69520627J016LB | Class C | Active |
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Manufacturer
- Manufacturer
- Anhui Deepblue Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000018785
- Authorised Representative
- Mega Eurostar Sp. z o.o. PL-AR-000042730
Sources (1)
- EUDAMED e095c20d-caba-4956-80f1-7e9c2cc622e5 61 fields · synced Oct 9, 2026