Identity
- Trade Name
- SONAS EUDAMED
- Device Name
- Gel Pad Kit EUDAMEDSONAS Operating Unit EUDAMED
- Model / Reference
- 100172 EUDAMED100052 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00860008615848 EUDAMED00860008615824 EUDAMED
- Basic UDI-DI
- 08600086158GPKRJ EUDAMED08600086158SONASVN EUDAMED
- Direct Marketing DI
- 00860008615848 EUDAMED00860008615824 EUDAMED
- EMDN Code
- Z12109006 BRAIN TISSUE MONITORING SYSTEMS EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass IIa 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
Sonas by Burl Concepts, Inc. — 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 | 08600086158GPKRJ | Class I | Active |
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Manufacturer
- Manufacturer
- Burl Concepts, Inc.
- EUDAMED SRN
- US-MF-000029626
- Authorised Representative
- ICON (LR) Limited IE-AR-000006507
Sources (2)
- EUDAMED b08ed33a-2636-4978-950e-9651754e23ed 61 fields · synced Jul 31, 2026
- EUDAMED e1d1f0f9-9ec2-4c2c-8621-b766c9c7e235 61 fields · synced May 18, 2026