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Ankle Support

by OPPO Medical Inc. United States EUDAMED

Ref 2001-BG-L

EMDN Y061299

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number08402706CL1024M Basic UDI-DIDate12 Sep 2024RegisteredStatusActive

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
Lower Extremity Orthoses
Model / Reference
2001-BG-L
Primary DI / UDI-DI
00840270601633
Basic UDI-DI
08402706CL1024M
EMDN Code
Y061299 Lower extremity orthoses - other
Device Class
Class I
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
US-MF-000005202
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Other devices from OPPO Medical Inc.

See all devices from OPPO Medical Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Contains Latex
Other properties (12)
  • Sterile: No
  • Implantable: No
  • Reusable: 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 8c11cb00-7e84-4050-937e-24e9ae4c18a8 61 fields · synced 22 Oct 2026