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Triple Transducer Connect

by Fujifilm Sonosite, Inc. United States EUDAMEDGUDID

Ref P16871-04RModel TRIPLE TRANSDUCER CONNECT, S-SERIES NON D2 COMPATIBLE Product code IYOEMDN Z1104018099

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00841517101626 Basic UDI-DIDate22 Oct 2025RegisteredStatusWithdrawn No longer placed on the EU market
United StatesGUDID listing GUDID Number00841517101626 UDI-DIDate21 Oct 2016ListedStatusWithdrawn

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 Withdrawn
  • United States GUDID listing Listed

Certificates: none listed in EUDAMED

Recalls

1 recall · FDA

    • Terminated Z-0027-2014 FDA Class II initiated 11 Sep 2013

    FUJIFILM SonoSite Inc. remove P21x/5-1 Transducer because the firm discovered the Biopsy Bracket Sensor is not working as intended.

Specification

EUDAMED · GUDID · synced 24 Oct 2026

Generic Name
General-purpose ultrasound imaging system
Device Name
Triple Transducer Connect, S-Series Non D2 Compatible
Model / Ref / Catalog
TRIPLE TRANSDUCER CONNECT, S-SERIES NON D2 COMPATIBLE, P16871-04R, P16871
Primary DI / UDI-DI
00841517101626
Basic UDI-DI
B-00841517101626
510(k) Number
FDA Product Code
IYO, ITX, IYN
EMDN Code
Z1104018099 Ultrasound scanners – hardware accessories – other
GMDN Term
General-purpose ultrasound imaging system
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
892.1560, 892.1570, 892.1550
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000001075
Authorised representative
Fujifilm Sonosite B.V. NL-AR-000000046

Other devices from Fujifilm Sonosite, Inc.

See all devices from Fujifilm Sonosite, Inc. →

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 3d2c1bf4-7802-49d6-859d-4490ababf31c 61 fields · synced 24 Oct 2026
  • FDA UDI d6f947bc-1dba-4dca-82f8-c8c66f01c2d2 37 fields · synced 30 May 2026