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Lumbo-Sacral Back Brace

by Dongguan Supercare Medical Products Co., Ltd China EUDAMED

Ref BK-008 MModel BK-001,BK-004,BK-006,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-052,BK-056,BK-072,BK-073,etc EMDN Y060306

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697278239BackBraceEB 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  • Withdrawn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 · synced 25 Oct 2026

Device Name
Lumbo-Sacral Back Brace
Model / Reference
BK-001, BK-004, BK-006, 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-052, BK-056, BK-072, BK-073, etc, BK-008 M
Primary DI / UDI-DI
06978927530013
Basic UDI-DI
697278239BackBraceEB
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 06978927530013|697278239BACKBRACEEB 61 fields · synced 25 Oct 2026