Identity
- Trade Name
- trophon AcuTrace Operator Card EUDAMED
- Device Name
- trophon AcuTrace Operator Card EUDAMED
- Model / Reference
- N05006 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09350855000276 EUDAMED
- Basic UDI-DI
- 93508550URTR-A-RFID-ZU EUDAMED
- EMDN Code
- Z12011399 CLEANING, DISINFECTION AND STERILISATION INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class I 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
trophon AcuTrace Operator Card by Nanosonics Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 93508550URTR-A-RFID-ZU | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nanosonics Limited
- EUDAMED SRN
- AU-MF-000014803
- Authorised Representative
- Nanosonics Europe GmbH DE-AR-000005870
Sources (1)
- EUDAMED 1ba95bae-219f-495f-8469-a8bfde39bb7e 61 fields · synced Aug 3, 2026