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trophon AcuTrace Medical Instrument Tag
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref N05007
Identity
- Trade Name
- trophon AcuTrace Medical Instrument Tag EUDAMED
- Device Name
- trophon AcuTrace Operator Card EUDAMED
- Model / Reference
- N05007 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09350855000283 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 Medical Instrument Tag by Nanosonics Limited — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
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 | K103059 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 93508550URTR-A-RFID-ZU | Class I | 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 8623f474-e16d-48a6-a676-3c0623a6caa9 61 fields · synced Jul 19, 2026
- FDA 510(k) K103059 1 fields · synced May 18, 2026