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EasyPrep electrodes
EUDAMEDFDA UDIClass I (EU MDR)
Ref EK-901Model EasyPrep Sensor Kit
Identity
- Trade Name
- EasyPrep electrodes EUDAMEDEasyPrep Sensor Kit FDA UDI
- Generic Name
- Analytical scalp electrode, single-use FDA UDI
- Device Name
- Electrodes EUDAMED
- Model / Reference
- EasyPrep Sensor Kit EUDAMEDEK-901 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- EK-901 FDA UDI
- Primary DI / UDI-DI
- ++B746EK901 EUDAMEDB746EK9011 FDA UDI
- Basic UDI-DI
- ++B746EK901UT EUDAMED
- 510(k) Number
- K202621 FDA UDI
- FDA Product Code
- GXY FDA UDI
- EMDN Code
- N01010299 EEG ELECTRODES - OTHER EUDAMED
- GMDN Term
- Analytical scalp electrode, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1320 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
EasyPrep electrodes by Neurowave Systems, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++B746EK901UT | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Neurowave Systems, Inc.
- EUDAMED SRN
- US-MF-000030995
- Authorised Representative
- AF Pharma Service Europe SL ES-AR-000018076
Sources (2)
- EUDAMED ab073293-d41d-4046-a5c3-7b32686566c4 61 fields · synced Jun 17, 2026
- FDA UDI 11b7cd2c-3625-42d3-81f8-4bb7d0f50ee2 34 fields · synced May 30, 2026