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Xela Rederm

by Yuria-pharm LLC Ukraine EUDAMED

Ref 2SNModel Injectable implant based on hyaluronic acid XELA REDERM 1,1% 2 ml

EMDN P900402

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-000034545XELAREDER2SNZN Basic UDI-DIDate9 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaLithuaniaNetherlandsPolandPolandPolandRomaniaSloveniaSpainSpainItalySpainSpainCroatiaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

EU market availability

Available in 12 countries, as listed in EUDAMED:

  • Croatiasince 2 Nov 2023
  • Cyprussince 24 Jan 2023
  • Finlandsince 9 Feb 2023
  • Italysince 20 Jul 2022
  • Latviasince 26 Jul 2022
  • Lithuaniasince 7 Jul 2022
  • Netherlandssince 28 Feb 2023
  • Polandsince 22 Aug 2022
  • Romaniasince 16 Jan 2023
  • Sloveniasince 2 Nov 2023
  • Spainsince 8 Mar 2023
  • Swedensince 16 Mar 2023

Last checked 23 Oct 2026.

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Injectable implant based on hyaluronic acid XELA REDERM
Model / Reference
Injectable implant based on hyaluronic acid XELA REDERM 1, 1% 2 ml, 2SN
Primary DI / UDI-DI
D-000034545XELAREDER2SNZN
Basic UDI-DI
B-000034545XELAREDER2SNZN
EMDN Code
P900402 Resorbable filling and reconstruction devices
Device Class
Class III
Market of Registration
Lithuania

Manufacturer details

EUDAMED SRN
UA-MF-000034545
Authorised representative
Diaco Biofarmaceutici srl IT-AR-000021064

Other devices from Yuria-pharm LLC

See all devices from Yuria-pharm LLC →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Implantable
Other properties (9)
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED D-000034545XELAREDER2SNZN|B-000034545XELAREDER2SNZN 61 fields · synced 22 Oct 2026