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Vessilen Kit

by Epitech Grop SpA Italy EUDAMED

Ref 6210Model 50 ml Vessilen® bottle + 50 ml Luer-Lock syringe + Luer- Lock needle + Luer-Lock adapter, all sterile.

EMDN U1302

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8031359VKIT55 Basic UDI-DIDate4 Jun 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
50 ml Vessilen® bottle + 50 ml Luer-Lock syringe + Luer- Lock needle + Luer-Lock adapter, all sterile., 6210
Primary DI / UDI-DI
08031359062106
Basic UDI-DI
8031359VKIT55
EMDN Code
U1302 Kits for bladder washing and instillation
Device Class
Class IIa
Medical Purpose
Vessilen® kit è un kit procedurale per instillazioni endo-vescicali composto da un flacone di Vessilen® 50 ml, una siringa da 50 ml Luer-Lock, un ago Luer-Lock e un adattatore Luer-Lock, tutti sterili. Il dispositivo medico Vessilen® 50 ml è destinato a formare una barriera protettiva e impermeabile che favorisce il naturale ripristino dell’integrità superficiale dell’urotelio, quando questa è alterata da situazioni dismetaboliche associate a noxae infiammatorie di diversa origine.

Manufacturer details

EUDAMED SRN
IT-PR-000040814

Other devices from Epitech Group SpA

See all devices from Epitech Group SpA →

Properties & raw data

Show properties, registry sources and raw records
Other properties (1)
  • Sterile: No

Sources (1)

  • EUDAMED 25f84fbb-8e1f-4807-a444-c6b8015c73aa 61 fields · synced 22 Oct 2026