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Lower limb brace

by Dongguan Supercare Medical Products Co., Ltd 31 variants

Ref FT-046 S-leftModel 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

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697278239LowerlimbbraceGD Basic UDI-DI 06972782391932UDI-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  • Withdrawn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
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, FT-046 S-left
Primary DI / UDI-DI
06972782391932
Basic UDI-DI
697278239LowerlimbbraceGD
EMDN Code
Y061203 Orthoses, foot (including insoles and inserts)
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

Related devices

Category: Orthotic insole, prefabricated, non-antimicrobial

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