Identity
- Device Name
- cortiQ PRO EUDAMED
- Model / Reference
- 8074 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 8074 EUDAMED
- Basic UDI-DI
- ++EBCI8060MA EUDAMED
- Direct Marketing DI
- 8074 EUDAMED
- EMDN Code
- Z12101104 CEREBRAL MAPPING SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Austria 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
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
cortiQ PRO by g.tec medical engineering GmbH — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K191432 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | ++EBCI8060MA | Class IIb | Active |
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Manufacturer
- Manufacturer
- g.tec medical engineering GmbH
- EUDAMED SRN
- AT-MF-000004562
Sources (2)
- EUDAMED dedbd97d-46f9-43f7-baa3-1f89b3a02576 61 fields · synced Jul 27, 2026
- FDA 510(k) K191432 1 fields · synced May 18, 2026