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ProfiTEX Lombosacral-Lombs I

by OrtoProfil Prod Romania SRL EUDAMED

Active European Union

Ref 4X.L-023-I

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5944784ORTPTCVLOMOSACRACM Basic UDI-DIDate25 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
Orteză lombosacrală
Model / Reference
4X.L-023-I
Primary DI / UDI-DI
05944784004487
Basic UDI-DI
5944784ORTPTCVLOMOSACRACM
Direct Marketing DI
05944784004487
EMDN Code
Y060308 Lumbosacral 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

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