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e-ASPECTS
EUDAMEDClass IIa (EU MDR)
Ref e-ASPECTS v11.3Model v11.3Ref e-ASPECTS 12.0Ref e-ASPECTS 12.1Ref e-ASPECTS v11Model 11.2Ref e-ASPECTS 14.3
Identity
- Trade Name
- e-ASPECTS EUDAMEDBrainomix 360 e-ASPECTS EUDAMED
- Device Name
- e-ASPECTS EUDAMEDBrainomix 360 e-ASPECTS EUDAMED
- Model / Reference
- v11.3 EUDAMEDe-ASPECTS v11.3 EUDAMEDe-ASPECTS 12.0 EUDAMEDe-ASPECTS 12.1 EUDAMED11.2 EUDAMEDe-ASPECTS v11 EUDAMEDe-ASPECTS 14.3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B720EASPECTS113CE0 EUDAMED*+B720EASPECTS120CE0 EUDAMED+B720EASPECTS121CE0- EUDAMED+B720EASPECTS112CE0 EUDAMED+B720EASPECTS143CE0/ EUDAMED
- Basic UDI-DI
- B-+B720EASPECTS113CE0 EUDAMED++B720EASPECTSCEGK EUDAMEDB-+B720EASPECTS112CE0 EUDAMED
- Direct Marketing DI
- *+B720EASPECTS120CE0/$$716819/16D202508217* EUDAMED+B720EASPECTS143CE0/ 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-ASPECTS 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-+B720EASPECTS113CE0 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-+B720EASPECTS113CE0 | 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 (5)
- EUDAMED d2a293ae-4ad8-4379-ae0e-cf05606c8f51 61 fields · synced Aug 5, 2026
- EUDAMED 5258b391-a922-4f20-ab5a-07b032c56d89 61 fields · synced May 18, 2026
- EUDAMED 655c2e8a-1412-42e6-9b75-e42266c9975f 61 fields · synced May 19, 2026
- EUDAMED b54398df-3bcb-421e-a67e-c1028371b098 61 fields · synced May 19, 2026
- EUDAMED e97e6cc5-a7bb-4535-98c9-ed88ab2a2532 61 fields · synced Jul 20, 2026