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Customized Back Support XL

by Customized innovations i Sverige AB EUDAMED

Active European Union

Ref CCS5047XLModel Customized Back Support

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number735012084Back01E4 Basic UDI-DIDate17 Jun 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  • Withdrawn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
Customized Back Support (S-XL)
Model / Reference
Customized Back Support, CCS5047XL
Primary DI / UDI-DI
07350120840141
Basic UDI-DI
735012084Back01E4
EMDN Code
Y060308 Lumbosacral spine orthoses
Device Class
Class I
Market of Registration
Sweden

Manufacturer details

EUDAMED SRN
SE-MF-000047918

From the manufacturer

Manufacturer's product page: Custom-ized Back SupportArticle number:CCS5047Sizes:S-XLMaterial:75% neuprene 20% nylon 5% metal support bar

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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