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604 Sol-Left M

by Aurafi̇x Health Products Diş Ti̇caret Ve Sanayi̇ Anoni̇m Şi̇rketi̇ Türkiye EUDAMED

Ref 604 SOL-LEFT MModel ORTHOPEDICS-HAND AND WRIST ORTHOSIS

EMDN Y060613

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number86803954ORT04X3 Basic UDI-DIDate14 Apr 2025RegisteredStatusActive

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
Orthopedics-Hand and Wrist Orthosis
Model / Reference
ORTHOPEDICS-HAND AND WRIST ORTHOSIS, 604 SOL-LEFT M
Primary DI / UDI-DI
08698779831950
Basic UDI-DI
86803954ORT04X3
Direct Marketing DI
08698779831950
EMDN Code
Y060613 Wrist-hand-fingers orthoses
Device Class
Class I
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000046503

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 c87d04fa-7944-4a5d-8770-e861fb812d9d 61 fields · synced 22 Oct 2026