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6Tc-RS

by GE Vingmed Ultrasound AS Norway EUDAMEDGUDID

Ref KN100106Model 6Tc

Product code ITXEMDN Z1104020302

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8406821BUG00273HH Basic UDI-DIDate8 Aug 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number00840682115735 UDI-DIDate15 Jul 2016ListedStatusIn 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
  • Active
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates: none listed in EUDAMED

Recalls

1 recall · FDA

    • Terminated Z-1964-2019 FDA Class II initiated 2 Jul 2019

    Potential for a transducer mis-alignment in certain transvaginal probes.

Specification

EUDAMED · GUDID · synced 24 Oct 2026

Trade Name
6Tc-RS EUDAMED
Na GUDID
Generic Name
Oesophageal ultrasound imaging transducer, reusable
Device Name
6Tc
Model / Reference
6Tc EUDAMED
KN100106 EUDAMED
6Tc-RS GUDID
Primary DI / UDI-DI
00840682115735
Basic UDI-DI
8406821BUG00273HH
510(k) Number
FDA Product Code
ITX, IYN, IYO
EMDN Code
Z1104020302 Transesophageal ultrasound probes, multidimensional
GMDN Term
Oesophageal ultrasound imaging transducer, reusable
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.1570, 892.1550, 892.1560
Market of Registration
France
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
6Tc
KN100106
GUDID
6Tc-RS
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
NO-MF-000000553

Other devices from Ge Vingmed Ultrasound

See all devices from Ge Vingmed Ultrasound →

Properties & raw data

Show properties, registry sources and raw records
  • Prescription Use
  • Serial Number
  • Manufacturing Date
Other properties (21)
  • Sterile: No
  • Single Use: No
  • 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
  • Lot / Batch Number: No
  • Expiration Date: No

Sources (2)

  • EUDAMED 510c2442-3a4b-4a06-aeff-deaf08e8dd67 61 fields · synced 24 Oct 2026
  • FDA UDI 41963ad5-14eb-44fe-829b-bca36b3f18b2 34 fields · synced 30 May 2026