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Epic™

by Abbott Medical 4 variants

Ref EMAX-27Model Epic Max Aortic

Epic™ (EMAX-27) is a Class III device made by Abbott Medical, registered in EUDAMED on 14 Sep 2026 (Basic UDI-DI 5415067SHV1101PJ), active as of 7 Nov 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5415067SHV1101PJ Basic UDI-DI 05415067045485UDI-DIDate14 Sep 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Epic Max Tissue Heart Valves
Model / reference
Epic Max Aortic, EMAX-27
Primary DI / UDI-DI
05415067045485
Basic UDI-DI
5415067SHV1101PJ
EMDN code
P070301010101 Stented aortic biological valves for surgical implant - valve tissue of animal origin
Device class
Class III
EU registration type
Standard device
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
US-MF-000018613
Authorised representative
Abbott Medical BE-AR-000008744

Similar devices in this category

Other devices filed under BIOLOGICAL CARDIAC VALVES FOR SURGICAL IMPLANT WITH SUPPORT.

Other devices from Abbott Medical

See all devices from Abbott Medical →

Properties

  • Supplied sterile
  • Implantable
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Contains animal tissues or cells
Other properties (10, all answered No)