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icobrain mr
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 5.17.z510(k) K180326
by icometrix
Identity
- Trade Name
- icobrain mr EUDAMED
- Device Name
- icobrain mr EUDAMED
- Model / Reference
- 5.17.z EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B621ICOBRAINMR5X17Y0 EUDAMED
- Basic UDI-DI
- ++B621ICOBRAINMREN EUDAMED
- Direct Marketing DI
- +B621ICOBRAINMR5X17Y0 EUDAMED
- EMDN Code
- V92 MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software 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
icobrain mr by icometrix — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
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 | K180326 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K161148 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | ++B621ICOBRAINMREN | Class IIa | Active |
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Manufacturer
- Manufacturer
- icometrix
- EUDAMED SRN
- BE-MF-000006329
Sources (2)
- EUDAMED ef48a659-b8a0-466a-9438-6d0f73b2dd19 85 fields · synced Jun 18, 2026
- FDA 510(k) K180326 1 fields · synced May 18, 2026