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Lumbo-Sacral Back Brace

by Dongguan Supercare Medical Products Co., Ltd China EUDAMED

Ref BR6B LModel BK-008 BK-009 BK-011 BK-012 BK-018 BK-019 BK-026 BK-036 BK-043 BK-044 BK-047 BK-049 BK-056 BK-072 BK-073 BK-074 BK-095 BK-101 BK-103 BK-104 BK-115 BK-055 BK-015 BK-017 etc

EMDN Y060306

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697892753BackBraceLE Basic UDI-DIDate13 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Lumbo-Sacral Back Brace
Model / Reference
BK-008 BK-009 BK-011 BK-012 BK-018 BK-019 BK-026 BK-036 BK-043 BK-044 BK-047 BK-049 BK-056 BK-072 BK-073 BK-074 BK-095 BK-101 BK-103 BK-104 BK-115 BK-055 BK-015 BK-017 etc, BR6B L
Primary DI / UDI-DI
06978927539566
Basic UDI-DI
697892753BackBraceLE
EMDN Code
Y060306 Thoracolumbar 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 06978927539566|697892753BACKBRACELE 61 fields · synced 24 Oct 2026