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XactTrace Extension Cable Thorax 78in/200cm
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1451072
Identity
- Trade Name
- XactTrace Extension Cable Thorax 78in/200cm EUDAMEDXltek FDA UDI
- Generic Name
- Polysomnograph FDA UDI
- Device Name
- XactTrace® Single Use Respiratory Effort Belt System EUDAMEDXactTrace Extension Cable Thorax 78in/200cm FDA UDI
- Model / Reference
- 1451072 EUDAMEDFDA UDI
- Description
- XactTrace Extension Cable Thorax 78in/200cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00382830026758 EUDAMEDFDA UDI
- Basic UDI-DI
- 038283NA00109EA EUDAMED
- Direct Marketing DI
- 00382830026758 EUDAMED
- 510(k) Number
- K173793 FDA UDI
- FDA Product Code
- MNR FDA UDI
- EMDN Code
- Z12100501 POLYSOMNOGRAPHS EUDAMED
- GMDN Term
- Polysomnograph FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.2375 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
XactTrace Extension Cable Thorax 78in/200cm by Natus Medical Incorporated Dba Excel-Tech Ltd (xltek) — Class IIa — 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 | 038283NA00109EA | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- EUDAMED SRN
- CA-MF-000004001
- Authorised Representative
- Natus Manufacturing Ltd IE-AR-000000884
Sources (2)
- EUDAMED 10a79dc4-1f40-4ce5-8660-3ad4e86338e4 61 fields · synced Jul 17, 2026
- FDA UDI 88ffabc2-c7dd-48b3-8b9f-f1a1b81e2f13 34 fields · synced May 30, 2026