Identity
- Trade Name
- H. pylori Antigen Rapid Test EUDAMED
- Device Name
- H. pylori Antigen Rapid Test EUDAMED
- Model / Reference
- IHP-N602-20 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936983104661 EUDAMED
- Basic UDI-DI
- 6970277510000JXV EUDAMED
- EMDN Code
- W0105090102 H. PYLORI - RT & POC EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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 Hangzhou Alltest Biotech.Co., Ltd. — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Unknown
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 6970277510000JXV | Class B | Unknown |
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Manufacturer
- Manufacturer
- Hangzhou Alltest Biotech.Co., Ltd.
- EUDAMED SRN
- CN-MF-000010710
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED b83b5b2a-ffa8-44de-84a0-ca988c8fa21d 61 fields · synced Jun 18, 2026