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Profusion EEG
EUDAMEDClass IIa (EU MDR)
Ref 8208-0063-01Model Profusion EEG Version 6Ref 8208-0065-01Model Profusion EEG Version 7Model Profusion EEG Version 7
Identity
- Trade Name
- Profusion EEG EUDAMED
- Device Name
- Profusion EEG EUDAMED
- Model / Reference
- Profusion EEG Version 6 EUDAMED8208-0063-01 EUDAMEDProfusion EEG Version 7 EUDAMED8208-0065-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09342451002419 EUDAMED09342451002792 EUDAMED
- Basic UDI-DI
- B-09342451002419 EUDAMEDB-09342451002792 EUDAMED9342451ProfusionEEGGG EUDAMED
- EMDN Code
- Z12100392 ELECTROENCEPHALOGRAPHY INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany 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
Yes
EUDAMEDEUDAMED
Incorporates Medicinal Product
No
EUDAMED
Profusion EEG by Compumedics 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-09342451002419 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-09342451002419 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Compumedics Limited
- EUDAMED SRN
- AU-MF-000050437
- Authorised Representative
- Compumedics EUROPE GmbH DE-AR-000039096
Sources (3)
- EUDAMED 2590df3f-5413-458f-bfbd-49edb5b310a7 61 fields · synced Sep 18, 2026
- EUDAMED 5893add5-489f-47c8-8fb9-94a15e664e87 61 fields · synced May 17, 2026
- EUDAMED 3a6f4724-b1b9-4591-b230-0d5dbd89f3c5 61 fields · synced Sep 18, 2026