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ProfiTEX orteză claviculară I

by OrtoProfil Prod Romania SRL Romania EUDAMED

Ref 4X.H-21-I EMDN Y060315

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5944784ORTPTCVCERVICOTO5N Basic UDI-DIDate25 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Orteză cervicotoracică
Model / Reference
4X.H-21-I
Primary DI / UDI-DI
05944784004289
Basic UDI-DI
5944784ORTPTCVCERVICOTO5N
Direct Marketing DI
05944784004289
EMDN Code
Y060315 Cervicothoracic spine orthoses
Device Class
Class I
Market of Registration
Romania

Manufacturer details

EUDAMED SRN
RO-MF-000000526

Other devices from OrtoProfil Prod Romania SRL

See all devices from OrtoProfil Prod Romania SRL →

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 42735703-eb61-441d-b128-3c550e18fa2b 61 fields · synced 23 Oct 2026