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Upper limb brace

by Dongguan Supercare Medical Products Co., Ltd 16 variants

Ref CY-002 UModel 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

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697278239UpperlimbbraceMN Basic UDI-DI 06972782392311UDI-DIDate20 Apr 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

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, CY-002 U
Primary DI / UDI-DI
06972782392311
Basic UDI-DI
697278239UpperlimbbraceMN
EMDN Code
Y060615 Elbow orthoses
Device Class
Class I
EU 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

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