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Upper limb brace

by Dongguan Supercare Medical Products Co., Ltd EUDAMED

Active European Union

Ref EB-020 uni-leftModel SD-001 SD-003 SD-004 SD-013 SD-014 FI-002 HJ-002 BM-003 EB-003 EB-004 EB-005 EB-009 EB-017 EB-020 EB-021 EB-022 EB-023 FG-001 FG-002 FG-003 FG-004 FG-005 FG-006A etc

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697278239UpperlimbbraceMN Basic UDI-DIDate20 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Upper limb brace
Model / Reference
SD-001 SD-003 SD-004 SD-013 SD-014 FI-002 HJ-002 BM-003 EB-003 EB-004 EB-005 EB-009 EB-017 EB-020 EB-021 EB-022 EB-023 FG-001 FG-002 FG-003 FG-004 FG-005 FG-006A etc, EB-020 uni-left
Primary DI / UDI-DI
06972782392151
Basic UDI-DI
697278239UpperlimbbraceMN
EMDN Code
Y060618 Elbow-wrist 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

Show 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