Identity
- Device Name
- trophon2 EUDAMED
- Model / Reference
- N05000-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09350855000313 EUDAMED
- Basic UDI-DI
- 93508550URTR-B-T2-CL EUDAMED
- Direct Marketing DI
- 09350855000306 EUDAMED
- EMDN Code
- Z12011380 CLEANING, DISINFECTION AND STERILISATION INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
trophon2 by Nanosonics Limited — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K173865 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K250434 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 93508550URTR-B-T2-CL | Class IIb | Active |
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Manufacturer
- Manufacturer
- Nanosonics Limited
- EUDAMED SRN
- AU-MF-000014803
- Authorised Representative
- Nanosonics Europe GmbH DE-AR-000005870
Sources (2)
- EUDAMED 00dd2383-d3db-43d2-885f-dfc1717e0216 61 fields · synced Aug 1, 2026
- FDA 510(k) K173865 1 fields · synced May 18, 2026