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Customized Kneesupport Neoprene XL

by Customized innovations i Sverige AB

Ref CCS8020XLModel Customized Knee support series

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number735012084Knee01MQ Basic UDI-DI 07350120844958UDI-DIDate18 Jun 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Customized Knee support (1.0, 1.0 active, 2.0. 3.0, 3.0 stabilize, neoprene, strap)
Model / Reference
Customized Knee support series, CCS8020XL
Primary DI / UDI-DI
07350120844958
Basic UDI-DI
735012084Knee01MQ
EMDN Code
Y061209 Knee orthoses
Device Class
Class I
EU market of registration
Sweden

Manufacturer details

EUDAMED SRN
SE-MF-000047918

From the manufacturer

Manufacturer's product page: Custom-ized Knee Support NeopreneArticle number:CCS8020Sizes:S-XLMaterial:Neoprene, Nylon, Gel, Metal support braces

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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