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Malecot Catheter Kit

by Biorad Medisys Pvt Ltd India EUDAMED

Ref BCMC2618040

EMDN U010103

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number890551611SW Basic UDI-DIDate30 Jul 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

Device Name
Malecot Catheter Kit
Model / Reference
BCMC2618040
Primary DI / UDI-DI
08905516009139
Basic UDI-DI
890551611SW
EMDN Code
U010103 Urethral prostatic and bladder catheters, malecot
Device Class
Class IIa
Market of Registration
France

Manufacturer details

EUDAMED SRN
IN-MF-000013050
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Biorad Medisys Pvt. Ltd.

See all devices from Biorad Medisys Pvt. Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (12)
  • 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 (1)

  • EUDAMED 2693115c-13ef-4426-8241-2e165897ef32 61 fields · synced 22 Oct 2026