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Dilagent

by SAPI MED S.p.A. Italy EUDAMED

Ref A.1004Model Anal Dilator

EMDN G06

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number803363880DLTORD6 Basic UDI-DIDate10 Sep 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Dilator
Model / Reference
Anal Dilator, A.1004
Primary DI / UDI-DI
08033638801123
Basic UDI-DI
803363880DLTORD6, 803363880DLTORKIT8U
EMDN Code
G06 Anal dilators
Device Class
Class I
Market of Registration
Italy
Medical Purpose
Allenamento pelvico / Dilatazione anale

Manufacturer details

EUDAMED SRN
IT-MF-000023733

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 (2)

  • EUDAMED 7685d154-1f37-4390-be39-bde00ee0f41f 61 fields · synced 23 Oct 2026
  • EUDAMED 08033638801123|803363880DLTORKIT8U 61 fields · synced 15 Oct 2026