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Trilogy Heart Valve

by JenaValve Technology, Inc. United States EUDAMEDGUDID

Ref TRILOGY-THV-S

Product code NPTEMDN P070301010101

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00850000898202 Basic UDI-DIDate19 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00850000898202 UDI-DIDate25 Mar 2026ListedStatusIn 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
  • 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

Trade Name
Trilogy Heart Valve EUDAMED
Trilogy Transcatheter Heart Valve GUDID
Generic Name
Aortic transcatheter heart valve bioprosthesis, stent-like framework
Model / Ref / Catalog
TRILOGY-THV-S
Primary DI / UDI-DI
00850000898202
Basic UDI-DI
B-00850000898202
FDA Product Code
NPT
EMDN Code
P070301010101 Stented aortic biological valves for surgical implant - valve tissue of animal origin
GMDN Term
Aortic transcatheter heart valve bioprosthesis, stent-like framework
Device Class
Class III
Market of Registration
Germany
Commercial Distribution
In Commercial Distribution
MRI Safety
MR Conditional

Manufacturer details

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

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Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Single Use
  • Implantable
  • Animal Tissues
  • Prescription Use
  • HCT/P
  • Serial Number
  • Expiration Date
  • Manufacturing Date
Other properties (13)
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • Premarket Exempt: No
  • Lot / Batch Number: No

Sources (2)

  • EUDAMED f03bb093-e379-41ac-8aac-e81c431961dd 61 fields · synced 23 Oct 2026
  • FDA UDI c4112c33-178f-438d-82ef-6d91f08a1f7f 37 fields · synced 23 Oct 2026