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Two-way Foley catheter

by Guangdong Ecan Medical Co., Ltd. 18 variants

Ref EC010216PModel Latex Urethral Catheters 2way Standard 5.3mm(16Fr） Silicon Coated plastic valve

Active European Union

CE MDD

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06941951012282 Basic UDI-DI 06941951012282UDI-DIDate18 Sep 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  • Withdrawn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/MDD Active

Specification

EUDAMED

Device Name
Urethral Catheters
Model / Reference
Latex Urethral Catheters 2way Standard 5.3mm(16Fr） Silicon Coated plastic valve, EC010216P
Primary DI / UDI-DI
06941951012282
Basic UDI-DI
B-06941951012282
EMDN Code
U020202 Ureteral catheters with flute tip with balloon
Device Class
Class IIa
EU market of registration
Poland

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

  • Contains Latex

Other properties (10)

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