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Friendship Medical NE-T-2000/17/0.40

by Xi'an Friendship Medical Electronics Co., Ltd. EUDAMEDGUDID

Active European Union and United States

Ref 1032Model NE-T-2000/17/0.4, NE-T, NE-P

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number16955739010329 UDI-DIDate10 May 2024ListedStatusIn distribution
European UnionCE/MDD EUDAMED NumberB-16955739010329 Basic UDI-DIDate23 Feb 2022RegisteredStatusActive
European UnionCE/MDR EUDAMED NumberB-16955739010329 Basic UDI-DIDate23 Feb 2022RegisteredStatusActive

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 AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDD, CE/MDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 23 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID

Trade Name
Friendship Medical
Generic Name
Subdermal needle electrode
Device Name
Disposable Subdermal Needle Electrodes(Twisted)
Disposable Subdermal Needle Electrodes
Model / Reference
NE-T-2000/17/0.4 EUDAMED
1032 EUDAMED
NE-T EUDAMED
NE-P EUDAMED
NE-T-2000/17/0.40 GUDID
Primary DI / UDI-DI
16955739010329
Basic UDI-DI
B-16955739010329, 695573901001KT
510(k) Number
FDA Product Code
GXZ
EMDN Code
Z121002 Nervous system monitoring systems
GMDN Term
Subdermal needle electrode
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
882.1350
Market of Registration
Italy
Commercial Distribution
In Commercial Distribution
Sterilization Method
Ethylene Oxide

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
NE-T-2000/17/0.4
1032
NE-T, NE-P
GUDID
NE-T-2000/17/0.40
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Cleared under the same submission (K072276)

Other devices from Xi'an Friendship Medical Electronics Co., Ltd.

See all devices from Xi'an Friendship Medical Electronics Co., Ltd. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (18)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No