Skip to content

The Insides System

by The Insides Company Limited United States EUDAMED

Ref PS005

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 23 Oct 2026

Model / Reference
PS005
Primary DI / UDI-DI
09421905447034
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
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

Sources (1)

  • EUDAMED d9da35fc-3ed9-49ec-a6eb-a731a73bfd9e 61 fields · synced 23 Oct 2026