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Gateway HV® Valved Adapter

by Galt Medical Corp.

Ref GWT-000-30Model GWT-XXX-XX

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

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 Number08412681ACL-HV6H Basic UDI-DI 00841268107236UDI-DIDate4 May 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number00841268107236 UDI-DI Date6 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.

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  • Withdrawn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
Gateway HV® Valved Adapter EUDAMED
Hemostasis Valve Adapter GUDID
Generic Name
Haemostasis valve
Device Name
Attachable Cath Lab Hemostasis
Model / Ref / Catalog
GWT-XXX-XX, GWT-000-30
Primary DI / UDI-DI
00841268107236
Basic UDI-DI
08412681ACL-HV6H
FDA Product Code
DTL
EMDN Code
C900101 Haemostasis valves
GMDN Term
Haemostasis valve
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
870.4290
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Sterilization Method
Ethylene Oxide

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II
SterileEUDAMED
No
GUDID
Yes

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 NoEUDAMEDYesGUDID
  • 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