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Spinal Support Brace

by Changzhou Pubang Medical Equipment Co., Ltd. EUDAMED

Active European Union

Ref GC-X04ⅠModel Thoracolumbar Spine Fixator:GC-X01、GC-X02、GC-X03Ⅰ、GC-X03 Ⅱ、GC-X04Ⅰ、GC-X04 Ⅱ、GC-X05、GC-X06、GC-X07、GC-X08 Head, neck and chest immobilizers：GC-Q01、GC-Q02、GC-Q03 etc

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697067603SpinalLX Basic UDI-DIDate8 Aug 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • 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
Spinal Support Brace
Model / Reference
Thoracolumbar Spine Fixator:GC-X01、GC-X02、GC-X03Ⅰ、GC-X03 Ⅱ、GC-X04Ⅰ、GC-X04 Ⅱ、GC-X05、GC-X06、GC-X07、GC-X08 Head, neck and chest immobilizers：GC-Q01、GC-Q02、GC-Q03 etc, GC-X04Ⅰ
Primary DI / UDI-DI
06970676032381
Basic UDI-DI
697067603SpinalLX
EMDN Code
Y060306 Thoracolumbar orthoses
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000048852
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Changzhou Pubang Medical Equipment Co., Ltd.

See all devices from Changzhou Pubang Medical Equipment 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