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Lower Limb Brace

by Shenzhen Aonuo Medical Technology Co., Ltd. EUDAMED

Active European Union

Model AN-301, AN-302, AN-303, AN-304, AN-305, AN-306, AN-307, AN-308, AN-309, AN-310, AN-311, AN-312, AN-313, AN-314, AN-315, AN-316, AN-317, AN-318, AN-319, AN-320, AN-321, AN-322, AN-323, AN-324, AN-325, AN-326, AN-327, AN-328 (or customized)

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697539269ANLLBS3 Basic UDI-DIDate13 Dec 2024RegisteredStatusActive

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  • Withdrawn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
Lower Limb Brace
Model / Reference
AN-301, AN-302, AN-303, AN-304, AN-305, AN-306, AN-307, AN-308, AN-309, AN-310, AN-311, AN-312, AN-313, AN-314, AN-315, AN-316, AN-317, AN-318, AN-319, AN-320, AN-321, AN-322, AN-323, AN-324, AN-325, AN-326, AN-327, AN-328 (or customized)
Primary DI / UDI-DI
06975392693045
Basic UDI-DI
697539269ANLLBS3
EMDN Code
Y061215 Hip orthoses (including abduction orthoses)
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000038823
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Shenzhen Aonuo Medical Technology Co., Ltd.

See all devices from Shenzhen Aonuo Medical Technology 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