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Disposable EEG Sensor
EUDAMEDClass I (EU MDR)
Ref MK-02Model MK-01 MK-02 MK-03 MK-04 MK-06 MK-08Ref MK-08Ref MK-04
Identity
- Device Name
- Disposable EEG Sensor EUDAMED
- Model / Reference
- MK-01 MK-02 MK-03 MK-04 MK-06 MK-08 EUDAMEDMK-02 EUDAMEDMK-08 EUDAMEDMK-04 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974452558805 EUDAMED06974452556542 EUDAMED06974452554449 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 |
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Manufacturer
- Manufacturer
- Medker Medical Electronic Tech (Shenzhen) Co., Ltd
- EUDAMED SRN
- CN-MF-000002911
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (3)
- EUDAMED de156829-0e4a-4b6f-983b-0db557d8e92b 61 fields · synced Jul 13, 2026
- EUDAMED 6a09b373-1fef-45fb-8ebe-1485a928caf3 61 fields · synced May 18, 2026
- EUDAMED fbc39c07-6623-441a-a0da-a14902fab731 61 fields · synced May 18, 2026