Identity
- Trade Name
- RheoPatch Sensor 2.0 EUDAMED
- Device Name
- RheoPatch 2.0 EUDAMED
- Model / Reference
- 30020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07649989882066 EUDAMED
- Basic UDI-DI
- 7649989882RP2.0U8 EUDAMED
- Direct Marketing DI
- 07649989882066 EUDAMED
- EMDN Code
- Z12109006 BRAIN TISSUE MONITORING SYSTEMS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
RheoPatch Sensor 2.0 by Luciole Medical AG — 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 | 7649989882RP2.0U8 | Class I | Active |
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Manufacturer
- Manufacturer
- Luciole Medical AG
- EUDAMED SRN
- CH-MF-000015856
- Authorised Representative
- Veranex Germany GmbH DE-AR-000005578
Sources (1)
- EUDAMED 4e3c029b-4fbf-4dcc-a931-afca55cb1dd2 61 fields · synced Jun 19, 2026