Identity
- Device Name
- Helicobacter Pylori Staining Solution EUDAMED
- Model / Reference
- EN ISO 14971 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977454210047 EUDAMED
- Basic UDI-DI
- 697745421HP4P EUDAMED
- EMDN Code
- W0105010499 H. PYLORI REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany 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
Helicobacter Pylori Staining Solution by Guangzhou Hearty Expression Medical Technology Co., Ltd. — Class A — IVDR — listed in EUDAMED
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 | 697745421HP4P | Class A | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000036085
- Authorised Representative
- Everbiz GmbH DE-AR-000008964
Sources (1)
- EUDAMED f877c924-6012-452d-bc61-d64ced49e336 61 fields · synced Jun 19, 2026