Identity
- Trade Name
- Brainomix 360 e-CTA EUDAMED
- Device Name
- Brainomix 360 e-CTA EUDAMED
- Model / Reference
- e-CTA 12.1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B720ECTA121RH02 EUDAMED
- Basic UDI-DI
- ++B720ECTACEQR 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-CTA by Brainomix Limited — Class IIb — 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 | ++B720ECTACEQR | 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 (1)
- EUDAMED 7fea4c5d-9023-483d-b4b4-e4346f6e0d37 61 fields · synced Jun 18, 2026