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Prosthetic parts

by Xiamen Nguard Technology Co., Ltd. EUDAMED

Active European Union

Ref Nguard Pin Silicone Liner BK_18Model Nguard Pin Silicone Liner BK，Nguard Pin Silicone Liner AK，Nguard Seal Silicone Liner BK，Nguard Seal Silicone Liner AK，Nguard Foot，Nguard Cushion Silicone Sheet，Nguard Sleeve ，Nguard Silicone Sleeve

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number698035244PSL001JM Basic UDI-DIDate27 Jul 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  • Withdrawn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
Prosthetic parts
Model / Reference
Nguard Pin Silicone Liner BK，Nguard Pin Silicone Liner AK，Nguard Seal Silicone Liner BK，Nguard Seal Silicone Liner AK，Nguard Foot，Nguard Cushion Silicone Sheet，Nguard Sleeve ，Nguard Silicone Sleeve, Nguard Pin Silicone Liner BK_18
Primary DI / UDI-DI
06980352440003
Basic UDI-DI
698035244PSL001JM
EMDN Code
Y061280 Lower limb orthoses - accessories
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000057445
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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