Identity
- Trade Name
- X Link EUDAMEDSTIMPOD X-LINK FDA UDI
- Generic Name
- Medical networking interface unit FDA UDI
- Device Name
- X Link EUDAMEDThe X-Link is intended to transmit data collected by the STIMPOD devices during NMT monitoring to a hospital's EMR (Electronic Medical Records) system via the hospital's network. This facilitates seamless integration of patient monitoring data into the hospital’s digital records, improving workflow efficiency and reducing manual entry errors. Additionally, the X-Link provides the capability to charge the STIMPOD NMS450X+ device when not in use (STIMPOD not in clinical use) and is disconnected from the patient, enhancing workflow efficiency in its operating environment. The product does not control any functionality of the STIMPOD devices. FDA UDI
- Model / Reference
- XT-45300 EUDAMEDFDA UDI
- Description
- The X-Link is intended to transmit data collected by the STIMPOD devices during NMT monitoring to a hospital's EMR (Electronic Medical Records) system via the hospital's network. This facilitates seamless integration of patient monitoring data into the hospital’s digital records, improving workflow efficiency and reducing manual entry errors. Additionally, the X-Link provides the capability to charge the STIMPOD NMS450X+ device when not in use (STIMPOD not in clinical use) and is disconnected from the patient, enhancing workflow efficiency in its operating environment. The product does not control any functionality of the STIMPOD devices. FDA UDI
Identifiers
- Catalog Number
- XT-45300 FDA UDI
- Primary DI / UDI-DI
- 06009880396610 EUDAMEDFDA UDI
- Basic UDI-DI
- 06009880396XT45300BP EUDAMED
- FDA Product Code
- OUG FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Medical networking interface unit FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6310 FDA UDI
- Market of Registration
- Italy 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Medical networking interface unit
Stimpod X-Link by Xavant Technology (pty) Ltd — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Xavant Technology (pty) Ltd
Sources (2)
- FDA UDI db8ec82b-d48c-4371-8303-cadec059f8fc 35 fields · synced Jul 15, 2026
- EUDAMED 0e13b1f0-bffc-4832-be15-71993826c993 61 fields · synced Jul 15, 2026