Identity
- Trade Name
- Stimulation Adapter Cable EUDAMEDBIONESS FDA UDI
- Generic Name
- Diagnostic peripheral nerve electrical stimulation system FDA UDI
- Device Name
- Stimulation Adapter Cable EUDAMEDThe adapter cable is connected to the ST2-3000 nerve stimulation device for deploying electrical stimulations . FDA UDI
- Model / Reference
- ST2-3100 EUDAMEDSTIMPOD ST2-3100 Stimulation Adapter Cable FDA UDI
- Description
- The adapter cable is connected to the ST2-3000 nerve stimulation device for deploying electrical stimulations . FDA UDI
Identifiers
- Catalog Number
- ST2-3100 FDA UDI
- Primary DI / UDI-DI
- 06009880396191 EUDAMEDFDA UDI
- Basic UDI-DI
- 06009880396ST231007L EUDAMED
- 510(k) Number
- K140853 FDA UDI
- FDA Product Code
- BXN FDA UDI
- EMDN Code
- Z12062899 NEUROMUSCULAR STIMULATION EQUIPMENT - OTHER EUDAMED
- GMDN Term
- Diagnostic peripheral nerve electrical stimulation system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.2775 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Stimulation Adapter Cable by Xavant Technology (pty) Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 06009880396ST231007L | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Xavant Technology (Pty) Ltd
- EUDAMED SRN
- ZA-MF-000011657
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED e715e45b-cbda-4d0c-8e87-f29f5a85496d 61 fields · synced Jun 19, 2026
- FDA UDI 02ac0fe0-b3ab-4355-9b20-f930d029d778 36 fields · synced May 30, 2026
- EUDAMED 4795825a-c226-4b9c-a34f-f5f23307fae6 61 fields · synced Jun 19, 2026