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Transcutaneous Electrical Nerve Stimulation System

by Shenzhen XFT Medical Limited United States EUDAMEDGUDID

Ref XFT-2000

Product code IPFEMDN Z12062799

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-06970670070228 Basic UDI-DIDate12 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number06970670070228 UDI-DIDate2 Jun 2020ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Listed
  • Not covered
  • European Union CE/MDD Expiring (legacy directive)
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Trade Name
Transcutaneous Electrical Nerve Stimulation System EUDAMED
XFT, SaeboStim Pro GUDID
Generic Name
Physical therapy transcutaneous neuromuscular electrical stimulation system
Device Name
Nerve and Muscle Stimulator
Model / Reference
XFT-2000, SaeboStim Pro
Primary DI / UDI-DI
06970670070228
Basic UDI-DI
B-06970670070228
510(k) Number
FDA Product Code
IPF, GZJ
EMDN Code
Z12062799 Functional electrical stimulation systems - other
GMDN Term
Physical therapy transcutaneous neuromuscular electrical stimulation system
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
890.5850, 882.5890
Market of Registration
Norway
Commercial Distribution
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
XFT-2000
GUDID
XFT-2000, SaeboStim Pro
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000034966
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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Properties & raw data

Show properties, registry sources and raw records
  • Serial Number
  • Manufacturing Date
Other properties (20)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No

Sources (2)

  • EUDAMED caa2324d-b042-45a1-9daf-e2675fa8f165 61 fields · synced 22 Oct 2026
  • FDA UDI 56d2bdcc-afb6-4c76-9784-3301f94ff3a4 33 fields · synced 30 May 2026