Identity
- Trade Name
- Trex HD Monitoring EUDAMEDNatus FDA UDI
- Generic Name
- Electroencephalograph FDA UDI
- Device Name
- Trex Ext. Battery Cable EUDAMEDTrex HD Monitoring FDA UDI
- Model / Reference
- PK1055HDM EUDAMEDFDA UDI
- Description
- Trex HD Monitoring FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00382830047777 EUDAMEDFDA UDI
- Basic UDI-DI
- 038283NA00094EN EUDAMED
- Direct Marketing DI
- 00382830047777 EUDAMED
- 510(k) Number
- K131266 FDA UDI
- FDA Product Code
- GWQ FDA UDI
- EMDN Code
- Z12100301 EEG SPECTRAL ANALYSERS EUDAMED
- GMDN Term
- Electroencephalograph FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1400 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Trex HD Monitoring by Natus Medical Incorporated Dba Excel-Tech Ltd (xltek) — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 038283NA00094EN | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- EUDAMED SRN
- CA-MF-000004001
- Authorised Representative
- Natus Manufacturing Ltd IE-AR-000000884
Sources (2)
- EUDAMED fd370ab6-b0eb-47b5-be78-b587fc9eecc1 61 fields · synced Jun 19, 2026
- FDA UDI deb34924-9411-4886-8d79-6edb1a17646e 34 fields · synced May 30, 2026