Skip to content

Profhilo

by Ibsa Farmaceutici Italia SRL 6 variants

Ref 8033638959657

Expiring European Union

CE MDR

Valid until

6 Jun 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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number803363895ID0055N Basic UDI-DI 08033638959657UDI-DIDate1 Apr 2026RegisteredStatusActive

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • EPT 0477.MDR.22/4845.1 Expiring Reissued Expires in 217 days

    Technical documentation EU MDR

    Certifier
    Eurofins Product Testing Italy S.r.l. 0477
    Issued
    26 Feb 2024
    Expires
    6 Jun 2027
  • EPT 0477.MDR.22/4846.1 Expiring Reissued Expires in 217 days

    Quality management system EU MDR

    Certifier
    Eurofins Product Testing Italy S.r.l. 0477
    Issued
    26 Feb 2024
    Expires
    6 Jun 2027

Coverage

1 jurisdiction

NetherlandsGermanyFranceBelgiumLuxembourgSlovakiaAustriaRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Expiring

EU market availability

Made available in 17 countries, as listed in EUDAMED:

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

  • Austria since 9 Feb 2015
  • Belgium since 9 Feb 2015
  • Bulgaria since 9 Feb 2015
  • Croatia since 9 Feb 2015
  • Cyprus since 9 Feb 2015
  • France since 9 Feb 2015
  • Germany since 9 Feb 2015
  • Greece since 9 Feb 2015
  • Italy since 9 Feb 2015
  • Luxembourg since 9 Feb 2015
  • Malta since 9 Feb 2015
  • Netherlands since 9 Feb 2015
  • Portugal since 9 Feb 2015
  • Romania since 9 Feb 2015
  • Slovakia since 9 Feb 2015
  • Slovenia since 9 Feb 2015
  • Spain since 9 Feb 2015

Last checked 1 Nov 2026.

Specification

EUDAMED

Device Name
HiLow Hyaluronic acid sodium salt for intradermal use
Model / Reference
8033638959657
Primary DI / UDI-DI
08033638959657
Basic UDI-DI
803363895ID0055N
Direct Marketing DI
08033638959657
EMDN Code
P900402 Resorbable filling and reconstruction devices
Device Class
Class III
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000008111

Other devices from IBSA Farmaceutici Italia Srl

See all devices from IBSA Farmaceutici Italia Srl →

Properties

  • Sterile
  • Implantable

Other properties (11)

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