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Duramesh Lyo

by Audio Technologies SRL 35 variants

Ref LYO-015X030H

Expiring European Union

CE MDR

Valid until

25 Aug 2027

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier Eurofins Product Testing Italy S.r.l.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805714354FT0034V Basic UDI-DI 08056138808713UDI-DIDate7 Apr 2026RegisteredStatusActive

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • EPT 0477.MDR.24/5441.1 Expiring Reissued Expires in 297 days

    Technical documentation EU MDR

    Certifier
    Eurofins Product Testing Italy S.r.l. 0477
    Issued
    24 Jun 2024
    Expires
    25 Aug 2027
  • EPT 0477.MDR.24/5442.1 Expiring Reissued Expires in 297 days

    Quality management system EU MDR

    Certifier
    Eurofins Product Testing Italy S.r.l. 0477
    Issued
    24 Jun 2024
    Expires
    25 Aug 2027

Coverage

1 jurisdiction

NorwayIcelandSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaLiechtensteinAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyTürkiyeCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Expiring

EU market availability

Made available in 32 countries, as listed in EUDAMED:

Declared by the manufacturer in EUDAMED for this device version; may not cover every market.

  • Austria since 12 Apr 2024
  • Belgium since 12 Apr 2024
  • Bulgaria since 12 Apr 2024
  • Croatia since 12 Apr 2024
  • Cyprus since 12 Apr 2024
  • Czechia since 12 Apr 2024
  • Denmark since 12 Apr 2024
  • Estonia since 12 Apr 2024
  • Finland since 12 Apr 2024
  • France since 12 Apr 2024
  • Germany since 12 Apr 2024
  • Greece since 12 Apr 2024
  • Hungary since 12 Apr 2024
  • Iceland since 12 Apr 2024
  • Ireland since 12 Apr 2024
  • Italy since 12 Apr 2024
  • Latvia since 12 Apr 2024
  • Liechtenstein since 12 Apr 2024
  • Lithuania since 12 Apr 2024
  • Luxembourg since 12 Apr 2024
  • Malta since 12 Apr 2024
  • Netherlands since 12 Apr 2024
  • Northern Ireland since 12 Apr 2024
  • Norway since 12 Apr 2024
  • Poland since 12 Apr 2024
  • Portugal since 12 Apr 2024
  • Romania since 12 Apr 2024
  • Slovakia since 12 Apr 2024
  • Slovenia since 12 Apr 2024
  • Spain since 12 Apr 2024
  • Sweden since 12 Apr 2024
  • Türkiye since 12 Apr 2024

Last checked 24 Oct 2026.

Specification

EUDAMED

Device Name
Collagen matrices for neurosurgery
Model / Reference
LYO-015X030H
Primary DI / UDI-DI
08056138808713
Basic UDI-DI
805714354FT0034V
EMDN Code
P900402 Resorbable filling and reconstruction devices
Device Class
Class III
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000010733

Other devices from Audio Technologies SRL

  • Duramesh Lyo

    Class III

  • Native 3D

    Class III

  • Braxon

    Class III

  • Native

    Class III

  • Braxon Fast

    Class III

  • Otosurgery prostheses

    Class IIb

See all devices from Audio Technologies SRL →

Properties

  • Sterile
  • Implantable
  • Animal Tissues

Other properties (10)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No