Skip to content

Foam Soft 38x10mm, Orange

by Koalaa Ltd

Ref KC11Model UPPER LIMB

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number506108178TOOLBX Basic UDI-DI 05061081780729UDI-DIDate21 Nov 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  • Withdrawn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
Prosthesis Consumable
Model / Reference
UPPER LIMB, KC11
Primary DI / UDI-DI
05061081780729
Basic UDI-DI
506108178TOOLBX
Direct Marketing DI
05061081780729
EMDN Code
Y061899 Upper extremity prostheses - other
Device Class
Class I
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
UK-MF-000045260
Authorised representative
European Healthcare & Device Solutions Ltd. IE-AR-000003999

Other devices from Koalaa

See all devices from Koalaa →

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