Identity
- Trade Name
- icobrain mr EUDAMED
- Device Name
- icobrain mr EUDAMED
- Model / Reference
- 6.16.z EUDAMED5.15.z EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B621ICOBRAINMR6X16Y0 EUDAMED+B621ICOBRAINMR5X15Y0 EUDAMED
- Basic UDI-DI
- ++B621ICOBRAINMREN EUDAMED
- Direct Marketing DI
- +B621ICOBRAINMR6X16Y0 EUDAMED+B621ICOBRAINMR5X15Y0 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 EUDAMEDBelgium 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 — 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 | ++B621ICOBRAINMREN | Class IIa | Active |
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Manufacturer
- Manufacturer
- icometrix
- EUDAMED SRN
- BE-MF-000006329
Sources (2)
- EUDAMED a945490f-40c1-4076-b6b4-01ca23fc11c2 61 fields · synced Sep 17, 2026
- EUDAMED dabb8cbf-a8e8-49ac-a7ef-3e763c285dac 61 fields · synced May 18, 2026