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e-CTP
EUDAMEDClass IIa (EU MDR)
Ref e-CTP v11.2Model v11.2Ref e-CTP/e-MRI 12.0Ref e-CTP v11Model v11.1Ref e-CTP/e-MRI 14.1Ref e-CTP v11.3Model v11.3Ref e-CTP/e-MRI 12.1
Identity
- Trade Name
- e-CTP EUDAMEDBrainomix 360 e-CTP/e-MRI EUDAMED
- Device Name
- e-CTP EUDAMEDBrainomix 360 e-CTP/e-MRI EUDAMED
- Model / Reference
- v11.2 EUDAMEDe-CTP v11.2 EUDAMEDe-CTP/e-MRI 12.0 EUDAMEDv11.1 EUDAMEDe-CTP v11 EUDAMEDe-CTP/e-MRI 14.1 EUDAMEDv11.3 EUDAMEDe-CTP v11.3 EUDAMEDe-CTP/e-MRI 12.1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B720ECTP112CE0 EUDAMED*+B720ECTP120CE0 EUDAMED+B720ECTP111CE0 EUDAMED*+B720ECTPEMRI141CE0 EUDAMED+B720ECTP113CE0 EUDAMED+B720ECTPEMRI121CE0. EUDAMED
- Basic UDI-DI
- B-+B720ECTP112CE0 EUDAMED++B720ECTPEMRICEL2 EUDAMEDB-+B720ECTP111CE0 EUDAMEDB-+B720ECTP113CE0 EUDAMED
- Direct Marketing DI
- *+B720ECTP120CE0/$$716819/16D20250821D* EUDAMED*+B720ECTPEMRI141CE0/$$717438/16D20250930A* EUDAMED+B720ECTPEMRI121CE0. EUDAMED
- EMDN Code
- Z11030592 RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass IIb EUDAMED
- Special Device Type
- -1192 EUDAMEDSoftware EUDAMED
- Market of Registration
- Northern Ireland EUDAMEDIreland EUDAMEDFinland 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
e-CTP by Brainomix Limited — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-+B720ECTP112CE0 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-+B720ECTP112CE0 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Brainomix Limited
- EUDAMED SRN
- GB-MF-000017336
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (6)
- EUDAMED 7f9e9e87-5bfb-4c85-9e3d-689e01e41251 61 fields · synced Aug 4, 2026
- EUDAMED beca05fd-aec0-40b3-b1f1-8e4ded71619f 61 fields · synced May 17, 2026
- EUDAMED 76a1cf76-20e4-463b-8763-e62cb38078be 61 fields · synced May 18, 2026
- EUDAMED a530ee86-c866-4811-8180-87aac80478fb 61 fields · synced May 18, 2026
- EUDAMED f83c6cf5-9fb4-416b-9c2e-1bc06f603ab0 61 fields · synced May 18, 2026
- EUDAMED 951ba415-e3ed-4be8-a8f9-3a5ed6d78f03 61 fields · synced Jun 20, 2026