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H.pylori Antigen Rapid Test Cassette (Feces)
EUDAMEDClass IVD General (EU MDR)
Ref IHP-602
Identity
- Trade Name
- H.pylori Antigen Rapid Test Cassette (Feces) EUDAMED
- Device Name
- H.pylori Antigen Rapid Test Cassette (Feces) EUDAMED
- Model / Reference
- IHP-602 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970277511049 EUDAMED
- Basic UDI-DI
- B-06970277511049 EUDAMED
- EMDN Code
- W0105090102 H. PYLORI - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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
H.pylori Antigen Rapid Test Cassette (Feces) by Hangzhou Alltest Biotech.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-06970277511049 | Class IVD General | Active |
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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 322b7ed6-711b-4567-a493-1d458eabbc37 61 fields · synced Jul 21, 2026