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NeuroWorks / SleepWorks Software
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 034877
Identity
- Trade Name
- NeuroWorks / SleepWorks Software EUDAMED
- Device Name
- NeuroWorks/SleepWorks 9.3.0 Installation Media (INTL) EUDAMED
- Model / Reference
- 034877 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00382830059534 EUDAMED
- Basic UDI-DI
- 038283NA00053E8 EUDAMED
- Direct Marketing DI
- 00382830059534 EUDAMED
- EMDN Code
- Z12100392 ELECTROENCEPHALOGRAPHY INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
NeuroWorks / SleepWorks Software by Natus Medical Incorporated Dba Excel-Tech Ltd (xltek) — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K980214 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K200878 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K180421 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 038283NA00053E8 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- CA-MF-000004001
- Authorised Representative
- Natus Manufacturing Ltd IE-AR-000000884
Sources (2)
- EUDAMED 1ab0c2a7-58bc-40bf-b41e-7630237b059b 61 fields · synced Jun 19, 2026
- FDA 510(k) K980214 1 fields · synced May 18, 2026