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Profhilo

by IBSA FARMACEUTICI ITALIA srl 6 variants

Ref 8033638959381

Active European Union

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number803363895IDK0057G Basic UDI-DI 08033638959381UDI-DIDate28 Aug 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
HiLow Hyaluronic acid sodium salt for intradermal use
Model / Reference
8033638959381
Primary DI / UDI-DI
08033638959381
Basic UDI-DI
803363895IDK0057G
EMDN Code
P900402 Resorbable filling and reconstruction devices
Device Class
Class III
Medical Purpose
PROFHILO® is indicated for adults of both sexes for a corrective/filling action of natural and induced skin depressions. PROFHILO® intervenes in the physiological process of the reduction of skin hydration, alteration of the elastic fibres and collagen of the dermis with loss of turgor and skin tone, for example in cases of excessive dehydration, weight loss and aging, with relative loss of endogenous HA. The viscoelastic and moisturising properties of HA, combined with the possibility of maintaining such HA at adequate levels in the skin tissues, allow rehydrating the tissues and creating the optimal conditions to prevent and to promote the tissue remodelling with consequent corrective effect on damages, for example in the scarring of the skin. Intradermal administration of PROFHILO® hence allows restoring the physiological quantity of HA in the treated tissues obtaining a benefit for the skin.

Manufacturer details

EUDAMED SRN
IT-PR-000050852

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Properties

  • Sterile