Identity
- Trade Name
- RheoControl EUDAMED
- Device Name
- RheoControl 3.0 EUDAMED
- Model / Reference
- 10030 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07649989882035 EUDAMED
- Basic UDI-DI
- 7649989882RC3.0RJ EUDAMED
- Direct Marketing DI
- 07649989882035 EUDAMED
- EMDN Code
- Z12109006 BRAIN TISSUE MONITORING SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
RheoControl by Luciole Medical AG — Class IIa — 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 | 7649989882RC3.0RJ | Class IIa | 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 578dc9c0-a5c2-4611-8fff-c4980c5e50e3 61 fields · synced Jul 12, 2026