Skip to content

The Insides System

by The Insides Company Limited United States EUDAMED

Ref PS040

EMDN G99

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number09421905447CHYMEUP Basic UDI-DIDate12 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
PS040
Primary DI / UDI-DI
09421905447270
Basic UDI-DI
09421905447CHYMEUP
EMDN Code
G99 Gastrointestinal devices - other
Device Class
Class IIb
Market of Registration
Northern Ireland

Manufacturer details

EUDAMED SRN
NZ-MF-000011306
Authorised representative
Advena Limited MT-AR-000000234

Other devices from The Insides Company Limited

See all devices from The Insides Company Limited →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (12)
  • 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

Sources (1)

  • EUDAMED 46f6046e-53a9-4e05-86a2-f1ed8160f917 61 fields · synced 22 Oct 2026