Identity
- Trade Name
- STIMPOD ST2-3000 EUDAMEDBIONESS FDA UDI
- Generic Name
- Diagnostic peripheral nerve electrical stimulation system FDA UDI
- Device Name
- ST2-3000 EUDAMEDPrecision Nerve Locator EUDAMEDThe STIMPOD ST2-3000 is a nerve stimulation device designed to be used for the purpose of nerve locating using percutaneous electrodes or needles (not supplied). FDA UDI
- Model / Reference
- ST2-3000 EUDAMEDSTIMPOD ST2-3000 KIT FDA UDI
- Description
- The STIMPOD ST2-3000 is a nerve stimulation device designed to be used for the purpose of nerve locating using percutaneous electrodes or needles (not supplied). FDA UDI
Identifiers
- Catalog Number
- ST2-3000 FDA UDI
- Primary DI / UDI-DI
- 06009880396184 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06009880396184 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 IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.2775 FDA UDI
- Market of Registration
- Czechia EUDAMED
- Commercial Distribution
- Not 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Stimpod St2-3000 by Xavant Technology (pty) Ltd — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06009880396184 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Xavant Technology (Pty) Ltd
- EUDAMED SRN
- ZA-MF-000011657
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 7900ac9a-a547-41e6-b4f1-28f901671100 61 fields · synced Jul 15, 2026
- FDA UDI 1e9d3f08-6454-4ad3-958b-557243bc1dce 36 fields · synced May 30, 2026
- EUDAMED eab43088-99c2-4e83-96c3-cb56d5a35191 61 fields · synced Jul 15, 2026