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Single Use Universal RIP Kit - Thorax
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1421051
Identity
- Trade Name
- Single Use Universal RIP Kit - Thorax EUDAMEDNatus FDA UDI
- Generic Name
- Polysomnograph FDA UDI
- Device Name
- XactTrace® Single Use Respiratory Effort Belt System EUDAMEDSingle Use Universal RIP Kit - Thorax FDA UDI
- Model / Reference
- 1421051 EUDAMEDFDA UDI
- Description
- Single Use Universal RIP Kit - Thorax FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00382830047463 EUDAMEDFDA UDI
- Basic UDI-DI
- 038283NA00109EA EUDAMED
- Direct Marketing DI
- 00382830047463 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
Yes
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
No
FDA UDI
Single Use Universal RIP Kit - Thorax 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 06001cb8-4029-48a3-8d7f-1381f5154f91 61 fields · synced Oct 6, 2026
- FDA UDI 5b0a3352-5c16-4c88-a546-f8e174ae6f79 34 fields · synced May 22, 2026