← Back to catalogue
Disposable EEG Sensor
EUDAMEDClass I (EU MDR)
Ref MK-06Model MK-01 MK-02 MK-03 MK-04 MK-06 MK-08
Identity
- Device Name
- Disposable EEG Sensor EUDAMED
- Model / Reference
- MK-01 MK-02 MK-03 MK-04 MK-06 MK-08 EUDAMEDMK-06 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974452552445 EUDAMED
- Basic UDI-DI
- 697445255EEGIMB EUDAMED
- EMDN Code
- Z12101080 EEG HOLTER SYSTEMS INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Disposable EEG Sensor by Medker Medical Electronic Tech (Shenzhen) Co., Ltd — Class I — 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 | 697445255EEGIMB | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medker Medical Electronic Tech (Shenzhen) Co., Ltd
- EUDAMED SRN
- CN-MF-000002911
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED aed0cd6d-917d-48e9-82ab-3cb9195b62ac 61 fields · synced Jun 18, 2026