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EMG Electrode Large
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref XT-45009LModel NMS450/NMS450X, NMS410, ST2-3000, NMS450X+
Identity
- Trade Name
- EMG Electrode Large EUDAMEDSTIMPOD FDA UDI
- Generic Name
- Diagnostic peripheral nerve electrical stimulation system FDA UDI
- Device Name
- STIMPOD EUDAMEDEMG ELECTRODE EUDAMEDElectrode array to be used with the STIMPOD NMS450 Nerve Stimulator FDA UDI
- Model / Reference
- NMS450/NMS450X, NMS410, ST2-3000, NMS450X+ EUDAMEDXT-45009L EUDAMEDEMG Electrode Large FDA UDI
- Description
- Electrode array to be used with the STIMPOD NMS450 Nerve Stimulator FDA UDI
Identifiers
- Catalog Number
- XT-45009L FDA UDI
- Primary DI / UDI-DI
- 06009880396573 EUDAMEDFDA UDI
- Basic UDI-DI
- 06009880396XT45000B8 EUDAMED06009880396XT45009BS EUDAMED
- 510(k) Number
- K213049 FDA UDI
- FDA Product Code
- BXN FDA UDI
- EMDN Code
- Z12062885 NEUROMUSCULAR STIMULATION EQUIPMENT - CONSUMABLES EUDAMED
- GMDN Term
- Diagnostic peripheral nerve electrical stimulation system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.2775 FDA UDI
- Market of Registration
- Czechia EUDAMEDItaly 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
Yes
EUDAMEDEUDAMED
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
EMG Electrode Large 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 06009880396XT45000B8 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 d74b91e5-3e60-41ac-aff0-69a89d2df3c4 61 fields · synced Jul 13, 2026
- FDA UDI 4f6d835c-8727-4e75-91a8-52a6bde17493 35 fields · synced May 30, 2026
- EUDAMED 882fd940-1bad-4a94-9804-cd1e25bcd065 61 fields · synced Jul 13, 2026