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Low Limb Support

by Duobest International Co., Ltd. EUDAMED

Active European Union

Ref ACA001M

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number471617172LLSKE Basic UDI-DIDate13 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • 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
Low Limb Support
Model / Reference
ACA001M
Primary DI / UDI-DI
04716171726897
Basic UDI-DI
471617172LLSKE
Direct Marketing DI
04716171726897
EMDN Code
Y061299 Lower extremity orthoses - other
Device Class
Class I
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
TW-MF-000037627
Authorised representative
KOMAS Medical Technology GmbH DE-AR-000045617

From the manufacturer

Manufacturer's product page: Orthopedic - Low Limb

Other devices from Duobest International Co., Ltd.

See all devices from Duobest International Co., Ltd. →

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