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Okti
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 9029-0016-01Model Okti Ethernet Connection KitRef 9029-0005-01Model Okti 128 Ch Ambulatory EEG SystemRef 9029-0015-01Model Okti 128 Ch Wall Mount System
Identity
- Trade Name
- Compumedics Okti FDA UDI
- Generic Name
- Electroencephalograph FDA UDI
- Device Name
- Okti EUDAMEDOkti 64 Channel Acquisition Module FDA UDI
- Model / Reference
- Okti Ethernet Connection Kit EUDAMED9029-0016-01 EUDAMEDOkti 128 Ch Ambulatory EEG System EUDAMED9029-0005-01 EUDAMEDOkti 128 Ch Wall Mount System EUDAMED9029-0015-01 EUDAMEDOkti 64 FDA UDI
- Description
- Okti 64 Channel Acquisition Module FDA UDI
Identifiers
- Catalog Number
- 8029-0003-01 FDA UDI
- Primary DI / UDI-DI
- 09342451005960 EUDAMED09342451005953 EUDAMED09342451007032 EUDAMED09342451002211 FDA UDI
- Basic UDI-DI
- B-09342451005960 EUDAMEDB-09342451005953 EUDAMEDB-09342451007032 EUDAMED
- 510(k) Number
- K230073 FDA UDI
- FDA Product Code
- GWQ FDA UDI
- EMDN Code
- Z12100302 ELECTROENCEPHALOGRAPHS EUDAMED
- GMDN Term
- Electroencephalograph FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1400 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Okti by Compumedics Limited — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K230073 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-09342451005960 | 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 (5)
- EUDAMED 2b315985-8766-4416-b88c-4afa5c96a435 61 fields · synced Jul 17, 2026
- EUDAMED 3aa71a96-7dd6-47a0-b3d9-40992556055e 61 fields · synced May 16, 2026
- EUDAMED 0f301bf7-8510-430f-a090-498d9102efac 61 fields · synced May 18, 2026
- FDA UDI 412a1177-eb49-49a4-9d92-02b70063ce9b 36 fields · synced May 29, 2026
- FDA 510(k) K230073 1 fields · synced May 18, 2026