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Back support/Lumbar support

by Irufa Industrial Group CO., LTD. EUDAMED

Active European Union

Ref BA-SF-1206 XXLModel Back support/Faja sacrolumbar/ Waist support/

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number471996166WAISTR9 Basic UDI-DIDate18 Feb 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  • Withdrawn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
Back support/Faja sacrolumbar/ Waist support
Model / Reference
Back support/Faja sacrolumbar/ Waist support/, BA-SF-1206 XXL
Primary DI / UDI-DI
04719961664485
Basic UDI-DI
471996166WAISTR9
EMDN Code
Y060308 Lumbosacral spine orthoses
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
TW-MF-000046083
Authorised representative
KHANG BAO INTERNATIONAL KFT HU-AR-000034102

From the manufacturer

Manufacturer's product page: Back/Waist Braces

Other devices from Irufa Industrial Group CO., LTD.

See all devices from Irufa Industrial Group 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