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Sterile Urinary Catheter for single use

by Jiangsu Suyun Medical Materials Co., Ltd. 402 variants

Model 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)

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69332982010V5 Basic UDI-DI 06933298297507UDI-DIDate22 Apr 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

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)
Primary DI / UDI-DI
06933298297507
Basic UDI-DI
69332982010V5
EMDN Code
U010202 Urethral prostatic and bladder catheters, couvelaire, with balloon
Device Class
Class IIa
EU 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

  • Sterile
  • Contains Latex

Other properties (11)

  • Implantable: No
  • Reusable: 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