UltraPro S100 4 Channel Amplifier
by Natus Neurology Incorporated
Ref 9031UP742
Active
CE MDR
Valid until
Not listed
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number038283NA00148EL 00382830059220 | Date14 Apr 2026 | StatusActive |
| United States | GUDID listing GUDID | Number00382830059220 | Date20 Nov 2020 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- UltraPro S100 4 Channel Amplifier EUDAMEDNicolet GUDID
- Generic Name
- Electromyograph
- Device Name
- UltraPro S100
- Model / Reference
- 9031UP742
- Primary DI / UDI-DI
- 00382830059220
- Basic UDI-DI
- 038283NA00148EL
- Direct Marketing DI
- 00382830059220
- FDA Product Code
- GWF
- EMDN Code
- Z12100401 Electromyographs
- GMDN Term
- Electromyograph
- Device Class
- Class IIb EUDAMEDClass II GUDID
- Regulation Number
- 882.1870
- EU market of registration
- Ireland
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIb | Class II |
Manufacturer details
- EUDAMED SRN
- US-MF-000004246
- Authorised representative
- Natus Manufacturing Ltd IE-AR-000000884
Other devices from Natus Neurology Incorporated
Properties
Other properties (20)
- 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
- Expiration Date: No