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ProfiTEX sacro-iliacă II

by OrtoProfil Prod Romania SRL Romania EUDAMED

Ref 4X.AHI-024-II

EMDN Y060303

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5944784ORTPTCVORTSILIACLC Basic UDI-DIDate25 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Orteză sacro-iliacă
Model / Reference
4X.AHI-024-II
Primary DI / UDI-DI
05944784004784
Basic UDI-DI
5944784ORTPTCVORTSILIACLC
Direct Marketing DI
05944784004784
EMDN Code
Y060303 Sacroiliac spine orthoses
Device Class
Class I
Market of Registration
Romania

Manufacturer details

EUDAMED SRN
RO-MF-000000526

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 82b39fc2-e4a4-4e02-b115-d031416e576a 61 fields · synced 22 Oct 2026