Skip to content

Durolane®

by Bioventus LLC

Ref 1082010

Durolane (1082010) is a medical device (EU MDD Class III; EMDN category resorbable filling and reconstruction devices) made by Bioventus LLC, registered in EUDAMED on 25 Oct 2024 (Basic UDI-DI B-00816986020181), active as of 23 Oct 2026.

Active European Union

CE MDD

Valid until

No date given

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

Source EUDAMED, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-00816986020181 Basic UDI-DI 00816986020181UDI-DIDate25 Oct 2024RegisteredStatusActive

Official records

Coverage

1 jurisdiction

NorwayIcelandSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaLiechtensteinAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyTürkiyeCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Map note: Northern Ireland has no dot of its own.

  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Liechtenstein
  • Lithuania
  • Luxembourg
  • Malta
  • Netherlands
  • Northern Ireland
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • Türkiye

Specification

EUDAMED

Device name
DUROLANE® hyaluronic acid, stabilized single injection (3mL)
Model / reference
1082010
Primary DI / UDI-DI
00816986020181
Basic UDI-DI
B-00816986020181
EMDN code
P900402 Resorbable filling and reconstruction devices
Device class
Class III
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000008452
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Similar devices in this category

Other devices filed under RESORBABLE FILLING AND RECONSTRUCTION DEVICES.

Other devices from Bioventus LLC

See all devices from Bioventus LLC →

Properties

  • Supplied sterile
  • Implantable
Other properties (10, all answered No)