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Sterile Urinary Catheter for single use

by Jiangsu Suyun Medical Materials Co., Ltd. China EUDAMED

Ref NAModel Silicone-2-way-2.0mm(6Fr/CH)-(Balloon capacity: 1.5cc/ml)、Silicone-2-way-2.7mm(8Fr/CH)-(Balloon capacity: 1-2cc/ml) 、Silicone-2-way-3.3mm(10Fr/CH)-(Balloon capacity: 3-5ml)、Silicone-2-way-4.0mm(12Fr/CH)-(Balloon capacity: 5-10ml)

EMDN U010202

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69332982010V5 Basic UDI-DIDate22 Apr 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
Sterile Urinary Catheter for single use
Model / Reference
Silicone-2-way-2.0mm(6Fr/CH)-(Balloon capacity: 1.5cc/ml)、Silicone-2-way-2.7mm(8Fr/CH)-(Balloon capacity: 1-2cc/ml) 、Silicone-2-way-3.3mm(10Fr/CH)-(Balloon capacity: 3-5ml)、Silicone-2-way-4.0mm(12Fr/CH)-(Balloon capacity: 5-10ml), NA
Primary DI / UDI-DI
16933298298396
Basic UDI-DI
69332982010V5
EMDN Code
U010202 Urethral prostatic and bladder catheters, couvelaire, with balloon
Device Class
Class IIa
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000021132
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Jiangsu Suyun Medical Materials Co., Ltd.

See all devices from Jiangsu Suyun Medical Materials 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 3f071e73-8efe-4338-a25d-3cfdf9fd76a8 61 fields · synced 22 Oct 2026