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Brainomix 360 e-CTP/e-MRI
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref e-CTP/e-MRI 14.2510(k) K223555
Identity
- Trade Name
- Brainomix 360 e-CTP/e-MRI EUDAMED
- Device Name
- Brainomix 360 e-CTP/e-MRI EUDAMED
- Model / Reference
- e-CTP/e-MRI 14.2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B720ECTPEMRI142CE0/ EUDAMED
- Basic UDI-DI
- ++B720ECTPEMRICEL2 EUDAMED
- Direct Marketing DI
- +B720ECTPEMRI142CE0 EUDAMED
- EMDN Code
- Z11030592 RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Ireland 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
Brainomix 360 e-CTP/e-MRI by Brainomix Limited — Class IIb — 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 | K231656 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K223555 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | ++B720ECTPEMRICEL2 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Brainomix Limited
- EUDAMED SRN
- GB-MF-000017336
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 1daa1f70-af92-4ab3-9a00-c1aa10876272 85 fields · synced Jun 18, 2026
- FDA 510(k) K231656 1 fields · synced May 18, 2026