Identity
- Trade Name
- LusioMATE EUDAMED
- Device Name
- LusioMATE EUDAMED
- Model / Reference
- LusioMATE V.2.0 EUDAMEDLusioMATE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09360087000005 EUDAMED
- Basic UDI-DI
- 9360087LUSIOMATE2Q7 EUDAMED
- EMDN Code
- Y99 DEVICES FOR PERSONS WITH DISABILITIES NOT INCLUDED IN OTHER CATEGORIES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
LusioMATE by Lusio Technology PTY Ltd — 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 | 9360087LUSIOMATE2Q7 | Class I | Active |
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Manufacturer
- Manufacturer
- Lusio Technology PTY Ltd
- EUDAMED SRN
- AU-MF-000031426
- Authorised Representative
- Eurolink Europe Compliance Limited IE-AR-000002852
Sources (1)
- EUDAMED be8f09fe-4511-46f3-ba47-22d9f2ea12bc 61 fields · synced Oct 6, 2026