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Chroma

by Uro Technology Sdn. Bhd. Malaysia EUDAMED

Ref 2121830

EMDN U010201

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-09555942804892 Basic UDI-DIDate22 Sep 2023RegisteredStatusActive

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 24 Oct 2026

Device Name
Sterile Urethral Latex Foley Balloon Catheters
Model / Reference
2121830
Primary DI / UDI-DI
09555942804892
Basic UDI-DI
B-09555942804892
EMDN Code
U010201 Urethral prostatic and bladder catheters, nelaton, with balloon
Device Class
Class IIb
Market of Registration
Estonia

Manufacturer details

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

Other devices from Uro Technology Sdn. Bhd.

See all devices from Uro Technology Sdn. Bhd. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Implantable
  • Contains Latex
Other properties (8)
  • Reusable: 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 f03a45bb-6cc1-4d90-ae31-f4c0de7f19cf 61 fields · synced 24 Oct 2026