Reusable Cup Electrodes
by Natus Neurology Incorporated United States EUDAMEDGUDID
Ref 019-772100
Product code GXYEMDN V9015
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number038283NA00017E4 | Date5 Nov 2025 | StatusActive |
| United States | GUDID listing GUDID | Number00382830039598 | Date23 Sep 2016 | StatusIn distribution |
Coverage
- Active
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Natus Neurology
- Generic Name
- Analytical scalp electrode, reusable
- Device Name
- Reusable Cup Electrodes
- Model / Reference
- 019-772100
- Primary DI / UDI-DI
- 00382830039598
- Basic UDI-DI
- 038283NA00017E4
- 510(k) Number
- FDA Product Code
- GXY
- EMDN Code
- V9015 Electrodes and probes cutaneous conductive substances
- GMDN Term
- Analytical scalp electrode, reusable
- Device Class
- Class I EUDAMEDClass II GUDID
- Regulation Number
- 882.1320
- Market of Registration
- France
- Commercial Distribution
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class I | Class II |
Manufacturer details
- EUDAMED SRN
- US-MF-000004246
- Authorised representative
- Natus Manufacturing Ltd IE-AR-000000884
Other devices from Natus Neurology Incorporated
Properties & raw data
Show properties, registry sources and raw records
Other properties (22)
- Sterile: No
- Single Use: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Expiration Date: No
- Manufacturing Date: No
Sources (2)
- EUDAMED 9419d05a-832a-4c8f-bc76-ec5867cf338a
- FDA UDI 74c72758-94a4-42a5-9c99-13821f837bf3