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Dr-B086

by A-Mi Global Co., Ltd. South Korea EUDAMED

Ref AMIDR-B086

EMDN Y060306

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number880925756083LG Basic UDI-DIDate11 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Spine Orthoses
Model / Reference
AMIDR-B086
Primary DI / UDI-DI
08809257567678
Basic UDI-DI
880925756083LG
EMDN Code
Y060306 Thoracolumbar orthoses
Device Class
Class I
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
KR-MF-000017572
Authorised representative
Advena Limited MT-AR-000000234

Other devices from Ami Global Co., Ltd

See all devices from Ami Global Co., Ltd →

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 08809257567678|880925756083LG 61 fields · synced 24 Oct 2026