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Silicone Urethral Catheter

by Guangdong Ecan Medical Co., Ltd. 12 variants

Ref EC020318SP, EC020108SP, EC020218SP, EC020216SP, EC020320SP, EC030618SD, EC020316SP, EC020116SY, EC020106SY, EC020324SP, EC030624SD, EC020108SY, EC020214SP, EC020110SP, EC020110SY, EC020114SY, EC020416CA, EC020106SP, EC020424CA, EC020120SY, EC020122SYModel 3 Way Standard， 6.0mm(18Fr），5ml/10ml/15ml/20ml/30ml/50ml, 2 Way Pediatric， 2.7mm(8Fr），3ml/5ml, 2 Way Standard ，6.0mm(18Fr），5ml/10ml/15ml/20ml/30ml, 2 Way Standard， 5.3mm(16Fr），5ml/10ml/15ml/20ml/30ml, 3 Way Standard， 6.7mm(20Fr），5ml/10ml/15ml/20ml/30ml/50ml, 3 Way Tiemann， 6.0mm(18Fr），5ml/10ml/15ml/20ml/30ml/50ml, 3 Way Standard， 5.3mm(16Fr），5ml/10ml/15ml/20ml/30ml/50ml, 1 Way 5.3mm(16Fr）, 1 Way 2.0mm(6Fr）, 3 Way Standard， 8.0mm(24Fr），5ml/10ml/15ml/20ml/30ml/50ml, 3 Way Tiemann， 8.0mm(24Fr），5ml/10ml/15ml/20ml/30ml/50ml, 1 Way 2.7mm(8Fr）, 2 Way Standard ，4.7mm(14Fr），5ml/10ml/15ml, 2 Way Pediatric ，3.3mm(10Fr），3ml/5ml, 1 Way 3.3mm(10Fr）, 1 Way 4.7mm(14Fr）, 2 Way Tiemann 5.3mm(16Fr），5ml/10ml/15ml/20ml/30ml, 2 Way Pediatric ，2.0mm(6Fr），1.5ml/3ml, 2 Way Tiemann， 8.0mm(24Fr），5ml/10ml/15ml/20ml/30ml/50ml, 2 Way Tiemann ，6.7mm(20Fr），5ml/10ml/15ml/20ml/30ml/50ml, 1 Way 6.7mm(20Fr）, 1 Way 7.3mm(22Fr）

Active European Union and United States

CE MDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K243011↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-06973362562360 Basic UDI-DI Date25 Apr 2026RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK243011 Date16 Jun 2025IssuedStatusActive

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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDD Active

Specification

EUDAMED · 510(k)

Model / Reference
3 Way Standard， 6.0mm(18Fr），5ml/10ml/15ml/20ml/30ml/50ml, EC020318SP, 2 Way Pediatric， 2.7mm(8Fr），3ml/5ml, EC020108SP, 2 Way Standard ，6.0mm(18Fr），5ml/10ml/15ml/20ml/30ml, EC020218SP, 2 Way Standard， 5.3mm(16Fr），5ml/10ml/15ml/20ml/30ml, EC020216SP, 3 Way Standard， 6.7mm(20Fr），5ml/10ml/15ml/20ml/30ml/50ml, EC020320SP, 3 Way Tiemann， 6.0mm(18Fr），5ml/10ml/15ml/20ml/30ml/50ml, EC030618SD, 3 Way Standard， 5.3mm(16Fr），5ml/10ml/15ml/20ml/30ml/50ml, EC020316SP, 1 Way 5.3mm(16Fr）, EC020116SY, 1 Way 2.0mm(6Fr）, EC020106SY, 3 Way Standard， 8.0mm(24Fr），5ml/10ml/15ml/20ml/30ml/50ml, EC020324SP, 3 Way Tiemann， 8.0mm(24Fr），5ml/10ml/15ml/20ml/30ml/50ml, EC030624SD, 1 Way 2.7mm(8Fr）, EC020108SY, 2 Way Standard ，4.7mm(14Fr），5ml/10ml/15ml, EC020214SP, 2 Way Pediatric ，3.3mm(10Fr），3ml/5ml, EC020110SP, 1 Way 3.3mm(10Fr）, EC020110SY, 1 Way 4.7mm(14Fr）, EC020114SY, 2 Way Tiemann 5.3mm(16Fr），5ml/10ml/15ml/20ml/30ml, EC020416CA, 2 Way Pediatric ，2.0mm(6Fr），1.5ml/3ml, EC020106SP, 2 Way Tiemann， 8.0mm(24Fr），5ml/10ml/15ml/20ml/30ml/50ml, EC020424CA, 2 Way Tiemann ，6.7mm(20Fr），5ml/10ml/15ml/20ml/30ml/50ml, 1 Way 6.7mm(20Fr）, EC020120SY, 1 Way 7.3mm(22Fr）, EC020122SY
Primary DI / UDI-DI
06973362562360, 06973362562254, 06973362562308, 06973362562292, 06973362562377, 06941951021000, 06973362562353, 06941951012633, 06941951012589, 06973362562391, 06941951021031, 06941951012596, 06973362562285, 06973362562261, 06941951012602, 06941951012626, 06941951012756, 06973362562247, 06941951012794, 06941951012770, 06941951012657, 06941951012664
Basic UDI-DI
B-06973362562360, B-06973362562254, B-06973362562308, B-06973362562292, B-06973362562377, B-06941951021000, B-06973362562353, B-06941951012633, B-06941951012589, B-06973362562391, B-06941951021031, B-06941951012596, B-06973362562285, B-06973362562261, B-06941951012602, B-06941951012626, B-06941951012756, B-06973362562247, B-06941951012794, B-06941951012770, B-06941951012657, B-06941951012664
EMDN Code
U010201 Urethral prostatic and bladder catheters, nelaton, with balloon
Device Class
Class IIa
EU market of registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000020906
Authorised representative
phoenix Medtech GmbH DE-AR-000007996

Other devices from Guangdong Ecan Medical Co., Ltd.

See all devices from Guangdong Ecan Medical Co., Ltd. →

Properties

  • Sterile

Other properties (10)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No