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Upper limb brace

by Dongguan Supercare Medical Products Co., Ltd EUDAMED

Active European Union

Ref FG-004 S, EB-003 uni, FG-006A 1, EB-004 uni, FG-008 U, CY-003 U, FI-002 s, EB-021 uni, FG-002 s, EB-022 uni left, SD-001, SD-013, FG-006B 0, EB-023 uni left, FG-003 s, FG-010 S, CY-001Model 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 28 Oct 2026

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

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • 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
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, FG-004 S, EB-003 uni, FG-006A 1, EB-004 uni, FG-008 U, CY-003 U, FI-002 s, EB-021 uni, FG-002 s, EB-022 uni left, SD-001, SD-013, FG-006B 0, EB-023 uni left, FG-003 s, FG-010 S, CY-001
Primary DI / UDI-DI
06972782392229, 06972782392106, 06972782392243, 06972782392113, 06972782392274, 06972782392328, 06972782392076, 06972782392168, 06972782392205, 06972782392175, 06972782392021, 06972782392052, 06972782392250, 06972782392182, 06972782392212, 06972782392281, 06972782392304
Basic UDI-DI
697278239UpperlimbbraceMN
EMDN Code
Y060603, Y060615, Y060621, Y060618, Y061203, Y060609
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

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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