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Okti
EUDAMEDClass IIa (EU MDR)
Ref 9029-0005-01Model Okti 64 Ch Ambulatory EEG System
Identity
- Device Name
- Okti EUDAMED
- Model / Reference
- Okti 64 Ch Ambulatory EEG System EUDAMED9029-0005-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09342451005946 EUDAMED
- Basic UDI-DI
- B-09342451005946 EUDAMED
- EMDN Code
- Z12100302 ELECTROENCEPHALOGRAPHS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Okti by Compumedics Limited — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-09342451005946 | 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 (1)
- EUDAMED 4654a370-f36a-47bc-84b3-6f89d053fd5b 61 fields · synced May 29, 2026