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Hinge

by Shijiazhuang RunYi Medical Device Technology Co., ltd China EUDAMED

Ref T001Model T001 T002 T003 T004 T005 T006 T007 T008 T009 T010 T011 T012 T013 T014 T015 T016 T017 T018 T019 T020 T021 T022 T023 T024 T025 T026 T027 T028 T029 T030 T031 T032 T033 T034 T035 T036 T037 T038 T039 T040 T041 T042 T043 T044 T045

EMDN Y061280

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697619156Hinge6N Basic UDI-DIDate17 Apr 2025RegisteredStatusActive

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
Hinge
Model / Reference
T001 T002 T003 T004 T005 T006 T007 T008 T009 T010 T011 T012 T013 T014 T015 T016 T017 T018 T019 T020 T021 T022 T023 T024 T025 T026 T027 T028 T029 T030 T031 T032 T033 T034 T035 T036 T037 T038 T039 T040 T041 T042 T043 T044 T045, T001
Primary DI / UDI-DI
06976191569999
Basic UDI-DI
697619156Hinge6N
EMDN Code
Y061280 Lower limb orthoses - accessories
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000034467
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Shijiazhuang RunYi Medical Device Technology Co., ltd

See all devices from Shijiazhuang RunYi Medical Device Technology Co., ltd →

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 2934583f-143d-470e-b935-40a522df5c42 61 fields · synced 22 Oct 2026