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Foley Balloon Catheters

by Yushin Medical Co., Ltd. South Korea EUDAMED

Ref 1011-18

EMDN U010206

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08809157670331 Basic UDI-DIDate9 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 24 Oct 2026

Device Name
Foley Balloon Catheters
Model / Reference
1011-18
Primary DI / UDI-DI
08809157670331
Basic UDI-DI
B-08809157670331
EMDN Code
U010206 Urethral prostatic and bladder catheters, tiemann with balloon
Device Class
Class IIb
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
KR-MF-000010526
Authorised representative
MPS Medical Product Service GmbH DE-AR-000005009

Other devices from Yushin Medical Co., Ltd.

See all devices from Yushin 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 49b014c5-29cc-4af0-b1ee-ea945ec8f4d7 61 fields · synced 24 Oct 2026