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Sinovial One

by IBSA FARMACEUTICI ITALIA srl 11 variants

Ref 8033638955093

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number803363895IAK0036B Basic UDI-DI 08033638955093UDI-DIDate3 Sep 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  • Withdrawn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

EU market availability

Not listed: EUDAMED names no country where this device is made available.

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

Last checked 29 Oct 2026.

Specification

EUDAMED

Device Name
Visco-suppletive joint device
Model / Reference
8033638955093
Primary DI / UDI-DI
08033638955093
Basic UDI-DI
803363895IAK0036B
EMDN Code
P900402 Resorbable filling and reconstruction devices
Device Class
Class III
Medical Purpose
Visco-suppletive joint device 0,8%: BRANDNAME® is a medical device designed to integrate the synovial fluid, which allows restoring the physiological and rheological properties of arthritic joints and tendons. BRANDNAME® reduces pain in the joint and encourages recovery of the associated joint and tendon mobility, acting only in the synovial cavity into which it is injected. Visco-suppletive joint device 1,6% and 2,0%: BRANDNAME® is a medical device designed to integrate the synovial fluid, which allows restoring the physiological and rheological properties of arthritic joints. BRANDNAME® reduces pain in the joint and encourages recovery of joint mobility, acting only in the synovial cavity into which it is injected.

Manufacturer details

EUDAMED SRN
IT-PR-000050852

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Properties

  • Sterile