Identity
- Device Name
- H. pylori Ag w kale - kasetki 20 szt. EUDAMED
- Model / Reference
- 1-302-K020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05902643958111 EUDAMED
- Basic UDI-DI
- 59026439BRT302J8 EUDAMED
- EMDN Code
- W0105090102 H. PYLORI - RT & POC EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
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 Ag w kale - kasetki 20 szt. by BioMaxima Spółka Akcyjna — Class B — 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 | 59026439BRT302J8 | Class B | Active |
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Manufacturer
- Manufacturer
- BioMaxima Spółka Akcyjna
- EUDAMED SRN
- PL-MF-000039473
Sources (1)
- EUDAMED 08d7c5b1-e841-4325-a35c-9e2dfc124499 61 fields · synced Jun 18, 2026