Identity
- Trade Name
- Neuroline Cup FDA UDI
- Generic Name
- Analytical scalp electrode, single-use FDA UDI
- Device Name
- Neurology surface electrodes FDA UDI
- Model / Reference
- 72615-M/15 FDA UDI
- Description
- Neurology surface electrodes FDA UDI
Identifiers
- Catalog Number
- 72615-M/15 FDA UDI
- Primary DI / UDI-DI
- 05707480146499 FDA UDI
- FDA Product Code
- GXY FDA UDI
- GMDN Term
- Analytical scalp electrode, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1320 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 150 Centimeter FDA UDI
Category: Analytical scalp electrode, single-use
Neuroline Cup by Ambu A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Analytical scalp electrode, single-use.
- Cadwell Single Disc Electrode — Cadwell Industries, Inc. · Class II
- Rhythmlink® — Rhythmlink International, LLC · Class II
- Rhythmlink® — Rhythmlink International, LLC · Class II
- Cadwell EEG Gold Cup Electrode — Cadwell Industries, Inc. · Class II
- Rhythmlink® — Rhythmlink International, LLC · Class II
- Zeto ONE Short-Term Electrode Set — ZETO INC · Class II
- BRAINSTREAM — Conmed Corporation · Class II
- Spes Medica Disc Electrode — SPES MEDICA SPA · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ambu A/S
Sources (1)
- FDA UDI c244d54f-1718-4c01-b350-974edf020987 37 fields · synced Jun 6, 2026