UltraPro S100 Main Base Unit
by Natus Neurology Incorporated
Ref 9033UP704
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 00382830058094 | Date14 Apr 2026 | StatusActive |
| United States | GUDID listing GUDID | Number00382830058094 | 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- Withdrawn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 Main Base Unit EUDAMEDNicolet GUDID
- Generic Name
- Electromyograph
- Device Name
- UltraPro S100
- Model / Reference
- 9033UP704
- Primary DI / UDI-DI
- 00382830058094
- Basic UDI-DI
- 038283NA00148EL
- Direct Marketing DI
- 00382830058094
- 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