e-CTA
by Brainomix Limited 2 variants
Ref e-CTA 11.3Model v11.3
Active
CE MDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-+B720ECTA113CE0 +B720ECTA113CE0 | Date10 Apr 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Model / Reference
- v11.3, e-CTA 11.3
- Primary DI / UDI-DI
- +B720ECTA113CE0
- Basic UDI-DI
- B-+B720ECTA113CE0
- EMDN Code
- Z11030592 Radiology instruments - medical device software
- Device Class
- Class IIa
- Special Device Type
- -1192
- EU market of registration
- Northern Ireland
Manufacturer details
- EUDAMED SRN
- GB-MF-000017336
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from Brainomix Limited
Properties
Other properties (11)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No