Identity
- Device Name
- Helicobacter Pylori Staining Solution EUDAMED
- Model / Reference
- EN ISO 14971 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977454210030 EUDAMED06977454210023 EUDAMED06977454210016 EUDAMED
- Basic UDI-DI
- 697745421HP4P EUDAMED697745421HP01MD EUDAMED
- EMDN Code
- W0105010499 H. PYLORI REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMEDAustria 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 (3)
- EUDAMED 4912a559-dd93-41bd-aca9-04649f7b6fa6 61 fields · synced Jul 28, 2026
- EUDAMED 05b438d6-7a60-46ec-9f10-117797d71670 61 fields · synced May 19, 2026
- EUDAMED cf639d24-abae-4b00-acdb-3b41f59218cd 61 fields · synced May 19, 2026