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Lower limb brace

by Dongguan Supercare Medical Products Co., Ltd China EUDAMED

Ref TH-001 SModel BK-055 BK-056 CF-002 CF-003 CF-005 TH-001 TH-003 TH-005 KN-001 KN-003 KN-005 KN-011 KN-012 KN-015 KN-016 KN-017 KN-026 KN-027 KN-028 KN-034 KN-037 KN-039 KN-040 KN-050 KN-052 KN-054 KN-055 KN-062 KN-065 KN-066 KN-069 KN-072 KN-075 etc

EMDN Y061217

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697278239LowerlimbbraceGD Basic UDI-DIDate20 Apr 2026RegisteredStatusActive

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 brace
Model / Reference
BK-055 BK-056 CF-002 CF-003 CF-005 TH-001 TH-003 TH-005 KN-001 KN-003 KN-005 KN-011 KN-012 KN-015 KN-016 KN-017 KN-026 KN-027 KN-028 KN-034 KN-037 KN-039 KN-040 KN-050 KN-052 KN-054 KN-055 KN-062 KN-065 KN-066 KN-069 KN-072 KN-075 etc, TH-001 S
Primary DI / UDI-DI
06972782391338
Basic UDI-DI
697278239LowerlimbbraceGD
EMDN Code
Y061217 Thigh orthoses
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000028597
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Dongguan Supercare Medical Products Co., Ltd

See all devices from Dongguan Supercare Medical Products 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 ebd73e74-877e-4008-a8f2-85c5b8024871 61 fields · synced 22 Oct 2026