Skip to content

Braxon Fast

by Audio Technologies SRL 3 variants

Ref FBRX06S

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 Number805714354FT0014R Basic UDI-DI 08057143540797UDI-DIDate7 Apr 2026RegisteredStatusActive

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • EPT 0477.MDR.22/4917 Expiring Expires in 297 days

    Technical documentation EU MDR

    Certifier
    Eurofins Product Testing Italy S.r.l. 0477
    Issued
    26 Aug 2022
    Expires
    25 Aug 2027
  • EPT 0477.MDR.22/4918 Expiring Expires in 297 days

    Quality management system EU MDR

    Certifier
    Eurofins Product Testing Italy S.r.l. 0477
    Issued
    26 Aug 2022
    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  • Withdrawn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 26 Aug 2022
  • Belgium since 26 Aug 2022
  • Bulgaria since 26 Aug 2022
  • Croatia since 26 Aug 2022
  • Cyprus since 26 Aug 2022
  • Czechia since 26 Aug 2022
  • Denmark since 26 Aug 2022
  • Estonia since 26 Aug 2022
  • Finland since 26 Aug 2022
  • France since 26 Aug 2022
  • Germany since 26 Aug 2022
  • Greece since 26 Aug 2022
  • Hungary since 26 Aug 2022
  • Iceland since 26 Aug 2022
  • Ireland since 26 Aug 2022
  • Italy since 26 Aug 2022
  • Latvia since 26 Aug 2022
  • Liechtenstein since 26 Aug 2022
  • Lithuania since 26 Aug 2022
  • Luxembourg since 26 Aug 2022
  • Malta since 26 Aug 2022
  • Netherlands since 26 Aug 2022
  • Northern Ireland since 26 Aug 2022
  • Norway since 26 Aug 2022
  • Poland since 26 Aug 2022
  • Portugal since 26 Aug 2022
  • Romania since 26 Aug 2022
  • Slovakia since 26 Aug 2022
  • Slovenia since 26 Aug 2022
  • Spain since 26 Aug 2022
  • Sweden since 26 Aug 2022
  • Türkiye since 26 Aug 2022

Last checked 24 Oct 2026.

Specification

EUDAMED

Device Name
Collagen matrices for breast surgery
Model / Reference
FBRX06S
Primary DI / UDI-DI
08057143540797
Basic UDI-DI
805714354FT0014R
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