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Polux

by BrosMed Medical Co., Ltd China EUDAMED

Ref 818-060015-070

EMDN C010402020101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number695848140011LU Basic UDI-DIDate20 Dec 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Polux PTA Balloon Dilatation Catheter
Model / Reference
818-060015-070
Primary DI / UDI-DI
06958481443516
Basic UDI-DI
695848140011LU
EMDN Code
C010402020101 PTA balloon dilatation catheters
Device Class
Class IIa
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000007501
Authorised representative
Brosmed Medical B.V. NL-AR-000002616

Other devices from BrosMed Medical Co., Ltd.

See all devices from BrosMed Medical Co., 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 06958481443516|695848140011LU 61 fields · synced 24 Oct 2026