Skip to content

Sinovial Hl

by IBSA FARMACEUTICI ITALIA srl 36 variants

Ref 8033638953532

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 Number803363895IAK00167 Basic UDI-DI 08033638953532UDI-DIDate25 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  • Withdrawn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 Visco-suppletive joint device
Model / Reference
8033638953532
Primary DI / UDI-DI
08033638953532
Basic UDI-DI
803363895IAK00167
EMDN Code
P900402 Resorbable filling and reconstruction devices
Device Class
Class III
Medical Purpose
SINOVIAL HL® with its particular formula belongs to the latest generation of intra-articular treatments. SINOVIAL HL® is a medical device designed to integrate the synovial fluid, which allows restoring the physiological and rheological properties of arthritic joints. SINOVIAL HL® reduces pain in the joint and encourages recovery of the associated joint mobility. Clinical data have demonstrated that SINOVIAL HL®, in combination with the laser terapy, can improve the symptomatology correlated to the tendinopathy.

Manufacturer details

EUDAMED SRN
IT-PR-000050852

Other devices from IBSA Farmaceutici Italia Srl

  • Profhilo

    Class III

  • Sinovial 50

    Class III

  • Viscoderm

    Class III

  • Hyaluxelle

    Class III

  • Ialuset

    Class IIb

  • Sinovial Hl

    Class III

See all devices from IBSA Farmaceutici Italia Srl →

Properties

  • Sterile