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Elite HV® R Introducer Kit

by Galt Medical Corp. United States EUDAMEDGUDID

Ref CLI-229-06Model CLI-2XX-XX

Product code DYBEMDN C900101

Regulatory status

as of 24 Oct 2026

Recall ongoing. 1 ongoing FDA recall. See recalls

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08412681HydroRadial-CLIPJ Basic UDI-DIDate3 May 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number00841268109339 UDI-DIDate11 Dec 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
  • Active
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates: none listed in EUDAMED

Recalls

3 recalls · 1 ongoing · FDA

    • Ongoing Z-1733-2025 FDA Class II initiated 27 Mar 2025

    Due to a potential open seal in the sterile barrier packaging .

  • 2 recalls, same reason

    • Terminated Z-2562-2018 FDA Class II initiated 2 May 2018
    • Terminated Z-2558-2018 FDA Class II initiated 2 May 2018

    The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient.

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Trade Name
Elite HV® R Introducer Kit EUDAMED
Elite HV® R Hydrophilic Introducer Kit GUDID
Generic Name
Haemostasis valve
Device Name
ELITE HV Hydrophilic Radial
Model / Ref / Catalog
CLI-2XX-XX, CLI-229-06
Primary DI / UDI-DI
00841268109339
Basic UDI-DI
08412681HydroRadial-CLIPJ
FDA Product Code
DYB
EMDN Code
C900101 Haemostasis valves
GMDN Term
Haemostasis valve
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
870.1340
Market of Registration
Belgium
Commercial Distribution
In Commercial Distribution
Sterilization Method
Ethylene Oxide
Size
Catheter Gauge — 6 French

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000001777
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Galt Medical Corp.

See all devices from Galt Medical Corp. →

Properties & raw data

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

Sources (2)

  • EUDAMED e6eb6331-36ce-4923-86e0-fe7de3b1a57e 61 fields · synced 22 Oct 2026
  • FDA UDI 14491b83-7f2d-446d-8a99-efe6f3b863de 36 fields · synced 26 May 2026