e-CTP
Ref e-CTP v11.2, e-CTP/e-MRI 12.0, e-CTP v11, e-CTP/e-MRI 14.1, e-CTP v11.3, e-CTP/e-MRI 12.1Model v11.2, v11.1, v11.3
e-CTP (e-CTP v11.2) is a device classified as Class IIa and Class IIb in the EU made by Brainomix Limited, registered in EUDAMED on 31 Jul 2024 (Basic UDI-DI B-+B720ECTP112CE0), active as of 22 Oct 2026.
Active
CE MDD
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-+B720ECTP112CE0 | Date31 Jul 2024 | StatusActive |
Official records
- EUDAMED public site B-+B720ECTP112CE0
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Trade name
- e-CTPBrainomix 360 e-CTP/e-MRI
- Model / reference
- v11.2, e-CTP v11.2, e-CTP/e-MRI 12.0, v11.1, e-CTP v11, e-CTP/e-MRI 14.1, v11.3, e-CTP v11.3, e-CTP/e-MRI 12.1
- Primary DI / UDI-DI
- +B720ECTP112CE0, *+B720ECTP120CE0, +B720ECTP111CE0, *+B720ECTPEMRI141CE0, +B720ECTP113CE0, +B720ECTPEMRI121CE0.
- Basic UDI-DI
- B-+B720ECTP112CE0, ++B720ECTPEMRICEL2, B-+B720ECTP111CE0, B-+B720ECTP113CE0
- Direct marketing DI
- *+B720ECTP120CE0/$$716819/16D20250821D**+B720ECTPEMRI141CE0/$$717438/16D20250930A*+B720ECTPEMRI121CE0.
- EMDN code
- Z11030592 Radiology instruments - medical device software
- Device class
- Class IIaClass IIb
- Special device type
- Software
- EU registration type
- Legacy device (under a directive)Standard device
- EU market of registration
- Northern IrelandIrelandFinland
Manufacturer details
- EUDAMED SRN
- GB-MF-000017336
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
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