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Chroma

by Uro Technology Sdn. Bhd. EUDAMED

Active European Union

Ref 2111230

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-09555942804663 Basic UDI-DIDate21 Sep 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Sterile Urethral Latex Foley Balloon Catheters
Model / Reference
2111230
Primary DI / UDI-DI
09555942804663
Market of Registration
Estonia

Manufacturer details

EUDAMED SRN
MY-MF-000001248
Authorised representative
Advena Limited MT-AR-000000234

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