Skip to content

Foley Catheter for single use [ latex Two-way with ballone) 4.0mm(12Fr)]

by Jiangxi Hongda Medical Equipment Group Ltd. China EUDAMED

Ref FR12D, FR14D, FR16D, FR20D, FR30D, FR28D, FR08DModel Model：Two-way with ballonet, Three-way with ballonet； Specifications：2.0mm(6Fr), 2.7mm(8Fr), 3.3mm(10Fr), 4.0mm(12Fr), 4.7mm(14Fr), 5.3mm(16Fr),6.0mm(18Fr),6.7mm(20Fr),7.3mm(22Fr),8.0mm(24Fr), 8.7mm(26Fr), 9.3mm(28Fr), 10.0mm(30Fr).

EMDN U020202

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69207567DNG0001GL Basic UDI-DIDate3 Feb 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Trade Name
Foley Catheter for single use [ latex Two-way with ballone) 4.0mm(12Fr)]
Foley Catheter for single use [ latex Two-way with ballone) 4.7mm(14Fr)]
Foley Catheter for single use [ latex Two-way with ballone) 5.3mm(16Fr)]
Foley Catheter for single use [ latex Two-way with ballone) 6.7mm(20Fr)]
Foley Catheter for single use [ latex Two-way with ballone 10.0mm(30Fr)]
Foley Catheter for single use [ latex Two-way with ballone 9.3mm(28Fr)]
Foley Catheter for single use latex Two-way with ballone 2.7mm(8Fr)
Device Name
Foley Catheter for single use
Model / Reference
Model：Two-way with ballonet, Three-way with ballonet； Specifications：2.0mm(6Fr), 2.7mm(8Fr), 3.3mm(10Fr), 4.0mm(12Fr), 4.7mm(14Fr), 5.3mm(16Fr), 6.0mm(18Fr), 6.7mm(20Fr), 7.3mm(22Fr), 8.0mm(24Fr), 8.7mm(26Fr), 9.3mm(28Fr), 10.0mm(30Fr)., FR12D, FR14D, FR16D, FR20D, FR30D, FR28D, FR08D
Primary DI / UDI-DI
06920756758366, 06920756758373, 06920756758380, 06920756758403, 06920756758458, 06920756758441, 06920756758342
Basic UDI-DI
69207567DNG0001GL
EMDN Code
U020202 Ureteral catheters with flute tip with balloon
Device Class
Class IIa
Market of Registration
Hungary

Manufacturer details

EUDAMED SRN
CN-MF-000006019
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Jiangxi Hongda Medical Equipment Group Co., Ltd.

See all devices from Jiangxi Hongda Medical Equipment Group Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (7)

  • EUDAMED b917b797-96c1-4a2d-86ae-1c4ed0b4fd92 61 fields · synced 24 Oct 2026
  • EUDAMED 06920756758373|69207567DNG0001GL 61 fields · synced 18 May 2026
  • EUDAMED 06920756758380|69207567DNG0001GL 61 fields · synced 18 May 2026
  • EUDAMED 06920756758403|69207567DNG0001GL 61 fields · synced 18 May 2026
  • EUDAMED 06920756758458|69207567DNG0001GL 61 fields · synced 18 May 2026
  • EUDAMED 06920756758441|69207567DNG0001GL 61 fields · synced 18 May 2026
  • EUDAMED 06920756758342|69207567DNG0001GL 61 fields · synced 19 May 2026