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Enema Bulb

by T2 Corporation Limited Hong Kong EUDAMED

Ref EB-2024-A006

EMDN G02060303

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5065007341EnemaBulbU2 Basic UDI-DIDate3 Dec 2024RegisteredStatusActive

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
EB-2024-A006
Primary DI / UDI-DI
05065007341063
Basic UDI-DI
5065007341EnemaBulbU2
EMDN Code
G02060303 Balloon catheters, barium enema
Device Class
Class I
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
HK-MF-000045342
Authorised representative
Kingsmead Service B.V. NL-AR-000002066

Other devices from T2 Corporation 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 cd66316f-d347-42b9-b7b5-0cc525ace7db 61 fields · synced 22 Oct 2026