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Ortotendon Max

by Rompharm Company SRL Romania EUDAMED

Ref HIALUROM TendonModel HIA_T5P EMDN P900402

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-05944728011311 Basic UDI-DIDate19 Jan 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Hyaluronate_tendon
Model / Reference
HIA_T5P, HIALUROM Tendon
Primary DI / UDI-DI
05944728011311
Basic UDI-DI
B-05944728011311
EMDN Code
P900402 Resorbable filling and reconstruction devices
Device Class
Class III
Market of Registration
Poland

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 (1)

  • EUDAMED a7bf8592-c84b-4417-ab70-a71901318cdf 61 fields · synced 22 Oct 2026