Identity
- Trade Name
- Digital Brain Electric Activity Mapping EUDAMED
- Device Name
- Digital Brain Electric Activity Mapping EUDAMED
- Model / Reference
- KT88 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945040100300 EUDAMED
- Basic UDI-DI
- 69450401KT88Q4 EUDAMED
- Direct Marketing DI
- 06945040100300 EUDAMED
- EMDN Code
- Z12100302 ELECTROENCEPHALOGRAPHS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Romania 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
Digital Brain Electric Activity Mapping by Contec Medical Systems Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69450401KT88Q4 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Contec Medical Systems Co., Ltd.
- EUDAMED SRN
- CN-MF-000007715
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (1)
- EUDAMED 48e5d954-4331-43ff-9b18-17c3b8c86e45 61 fields · synced Jun 11, 2026