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Trilogy Loading Tools

by JenaValve Technology, Inc. United States EUDAMEDGUDID

Ref TRILOGY-LT-L, TRILOGY-LT-S, TRILOGY-LT-M

Product code NPTEMDN P07038002

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00850000898189 UDI-DIDate25 Mar 2026ListedStatusIn distribution
European UnionCE/MDD EUDAMED NumberB-00850000898189 Basic UDI-DIDate25 Aug 2023RegisteredStatusActive

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
  • Expiring (legacy directive)
  • Listed
  • Not covered
  • European Union CE/MDD Expiring (legacy directive)
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 23 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 23 Oct 2026

Generic Name
Vascular guide-catheter, single-use
Device Name
Trilogy Loading Tools Size 27
Trilogy Loading Tools Size 23
Trilogy Loading Tools Size 25
Model / Ref / Catalog
TRILOGY-LT-L, TRILOGY-LT-S, TRILOGY-LT-M
Primary DI / UDI-DI
00850000898189, 00850000898165, 00850000898172
Basic UDI-DI
B-00850000898189, B-00850000898165, B-00850000898172
FDA Product Code
NPT
EMDN Code
P07038002 Cardiac valve transcatheter implant accessories
GMDN Term
Vascular guide-catheter, single-use
Device Class
Class III
Market of Registration
Germany
Commercial Distribution
In Commercial Distribution

Manufacturer details

EUDAMED SRN
US-MF-000023455
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from JenaValve Technology, Inc.

See all devices from JenaValve Technology, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date
Other properties (16)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: 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
  • Serial Number: No

Sources (6)

  • EUDAMED 492fbfc6-e835-4729-b497-15103ced5b48 61 fields · synced 22 Oct 2026
  • EUDAMED 00850000898165|B-00850000898165 61 fields · synced 17 May 2026
  • EUDAMED 00850000898172|B-00850000898172 61 fields · synced 18 May 2026
  • FDA UDI 39e8eb61-b981-4632-99c1-4e559e360313 37 fields · synced 23 Oct 2026
  • FDA UDI 4f589768-17e4-41cd-a1a2-fd8120081d56 37 fields · synced 23 Oct 2026
  • FDA UDI ba390b3d-1e07-42d5-970f-7f67b57ae0a2 37 fields · synced 23 Oct 2026