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SERTOBEC Tendon

by Rompharm Company SRL Romania EUDAMED

Ref HIALUROM Tendon, SERTOBECModel HIA_T5P, HIA_IA4V EMDN P900402

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-05944728007307 Basic UDI-DIDate20 Jan 2026RegisteredStatusWithdrawn No longer placed on the EU market

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Trade Name
SERTOBEC Tendon
Sertobec
Device Name
Hyaluronate_tendon
Hyaluronate_intraarticular
Model / Reference
HIA_T5P, HIALUROM Tendon, HIA_IA4V, SERTOBEC
Primary DI / UDI-DI
05944728007307, 05944728007192
Basic UDI-DI
B-05944728007307, B-05944728007192
EMDN Code
P900402 Resorbable filling and reconstruction devices
Device Class
Class III
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
RO-MF-000002517

Other devices from Rompharm Company SRL

See all devices from Rompharm Company SRL →

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 (2)

  • EUDAMED 7ac61eb4-6e58-4dec-b7bf-c5d18c0960cd 61 fields · synced 25 Oct 2026
  • EUDAMED 05944728007192|B-05944728007192 61 fields · synced 18 May 2026