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Elite HV® Introducer Kit

by Galt Medical Corp. 19 variants

Ref CLI-101-06Model CLI-1XX-XX

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 26 Oct 2026. What this means

Regulatory status

as of registry sync 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08412681MA-CLI6Y Basic UDI-DI 00841268103276UDI-DIDate3 May 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number00841268103276 UDI-DI Date23 Feb 2018ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Elite HV® Introducer Kit EUDAMED
Micro-Access Elite HV Introducer Set GUDID
Generic Name
Haemostasis valve
Device Name
Cath-Lab Introducer Kit Product Family
Model / Ref / Catalog
CLI-1XX-XX, CLI-101-06
Primary DI / UDI-DI
00841268103276
Basic UDI-DI
08412681MA-CLI6Y
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
EU market of registration
Belgium
GUDID distribution status
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

  • 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