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Lower Limb/Upper Limb Prosthetics Parts

by Bei Jing HeLiKang prosthetics Co., Ltd China EUDAMED

Ref HQ5SModel HQ5S-1, HQ5S, HQ401, HQ411, HQ412, HQ413, HQ401-C, HA1608, HA1618HA1628, HAS1608, HAS1618, H1711S-1, H1711S-2, H1711S-3, H1711S-4, H1711S-5, H1517A, H1518A, H1519A, H1520-160A/S/T, etc

EMDN P09010301

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697735375LLULPP3H Basic UDI-DIDate17 Apr 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 Limb/Upper Limb Prosthetics Parts
Model / Reference
HQ5S-1, HQ5S, HQ401, HQ411, HQ412, HQ413, HQ401-C, HA1608, HA1618HA1628, HAS1608, HAS1618, H1711S-1, H1711S-2, H1711S-3, H1711S-4, H1711S-5, H1517A, H1518A, H1519A, H1520-160A/S/T, etc
Primary DI / UDI-DI
06977353750002
Basic UDI-DI
697735375LLULPP3H
EMDN Code
P09010301 Metal back and metaglene glenoid baseplates
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000041021
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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 f097025f-0bf9-4c21-964b-c75215cead44 61 fields · synced 22 Oct 2026