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Instylan 0.16%

by Diaco Biofarmaceutici srl Italy EUDAMED

Ref 6011Model Sterile solution for intravescical administration 0.16% 50 ml

EMDN U1301

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-MD601166 Basic UDI-DIDate16 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
Sterile solution for intravescical administration 0.16% 50 ml, 6011
Primary DI / UDI-DI
D-MD601166
Basic UDI-DI
B-MD601166
EMDN Code
U1301 Solutions for bladder washing and instillation
Device Class
Class IIa
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000012117

Other devices from Diaco Biofarmaceutici srl

See all devices from Diaco Biofarmaceutici srl →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (10)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED dca69a80-4f53-4085-bb9f-90f5f6117054 61 fields · synced 22 Oct 2026