Identity
- Device Name
- Dengue NS1 kasetki 20 szt. EUDAMED
- Model / Reference
- 1-354-K020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05902643958623 EUDAMED
- Basic UDI-DI
- 59026439BRT354JT EUDAMED
- EMDN Code
- W0105099007 DENGUE - 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
Dengue NS1 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 | 59026439BRT354JT | Class B | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- BioMaxima Spółka Akcyjna
- EUDAMED SRN
- PL-MF-000039473
Sources (1)
- EUDAMED 7a3c8b12-95c9-4940-b309-89904d7433e6 61 fields · synced Oct 6, 2026