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Precision Nerve Locator

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref ST2-4010Model NMS450/NMS450X, NMS410, ST2-3000, NMS450X+

by Xavant Technology (Pty) Ltd

Identity

Trade Name
Precision Nerve Locator EUDAMED
BIOVENTUS FDA UDI
Generic Name
Diagnostic peripheral nerve electrical stimulation system FDA UDI
Device Name
STIMPOD EUDAMED
The STIMPOD ST2-4010 is a nerve stimulation device designed to be used for the purpose of nerve locating using invasive electrodes or needles (not supplied). The STIMPOD ST2-4010 is a precision nerve locating tool used for localizing specific neural pathways. Localization of nerves by electrical stimulation involves connecting the nerve stimulator to a conducting needle. FDA UDI
Model / Reference
NMS450/NMS450X, NMS410, ST2-3000, NMS450X+ EUDAMED
ST2-4010 EUDAMED
STIMPOD ST2-4010 FDA UDI
Description
The STIMPOD ST2-4010 is a nerve stimulation device designed to be used for the purpose of nerve locating using invasive electrodes or needles (not supplied). The STIMPOD ST2-4010 is a precision nerve locating tool used for localizing specific neural pathways. Localization of nerves by electrical stimulation involves connecting the nerve stimulator to a conducting needle. FDA UDI

Identifiers

Catalog Number
ST2-4010 FDA UDI
Primary DI / UDI-DI
06009880396443 EUDAMEDFDA UDI
Basic UDI-DI
06009880396XT45000B8 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 EUDAMED
Class II FDA UDI
Regulation Number
868.2775 FDA UDI
Market of Registration
Germany 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

Yes

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
MRI Safety
MR Unsafe FDA UDI

Precision Nerve Locator by Xavant Technology (pty) Ltd — Class IIa — 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

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Manufacturer

EUDAMED SRN
ZA-MF-000011657
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (2)

  • EUDAMED 5f970b4c-14ed-46f9-82f3-f63d07f49eb7 61 fields · synced Jun 17, 2026
  • FDA UDI aa55dfeb-817f-4051-84dc-8fe17e6d11fa 36 fields · synced May 29, 2026