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Hialurom

by Rompharm Company SRL Romania EUDAMED

Ref HIALUROMModel HIA_IA4V EMDN P900402

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-05944728007147 Basic UDI-DIDate11 May 2022RegisteredStatusActive

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  • Withdrawn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 25 Oct 2026

Device Name
Hyaluronate_intraarticular
Model / Reference
HIA_IA4V, HIALUROM
Primary DI / UDI-DI
05944728007147, 05944728007208, 05944728011472, 05944728011465, 05944728007123, 05944728007215
Basic UDI-DI
B-05944728007147, B-05944728007208, B-05944728011472, B-05944728011465, B-05944728007123, B-05944728007215
EMDN Code
P900402 Resorbable filling and reconstruction devices
Device Class
Class III
Market of Registration
Romania
Bulgaria

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
  • Administering Medicine NoEUDAMEDYesEUDAMED
Other properties (8)
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (6)

  • EUDAMED a8b26116-f25a-446a-8dab-3f21c68b23c6 61 fields · synced 22 Oct 2026
  • EUDAMED 05944728007208|B-05944728007208 61 fields · synced 11 Oct 2026
  • EUDAMED 05944728011472|B-05944728011472 61 fields · synced 13 Oct 2026
  • EUDAMED 05944728011465|B-05944728011465 61 fields · synced 24 Oct 2026
  • EUDAMED 05944728007123|B-05944728007123 61 fields · synced 24 Oct 2026
  • EUDAMED 05944728007215|B-05944728007215 61 fields · synced 25 Oct 2026