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Sterile Single-use All-Silicone Foley Balloon Catheter (Temperature Sensing)

by Sewoon Medical Co., Ltd. 4 variants

Ref 2105-020

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08806369440714 Basic UDI-DI 08806369440714UDI-DIDate21 Oct 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  • Withdrawn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
Sterile Single-use All-Silicone Foley Balloon Catheter (Temperature Sensing)
Model / Reference
2105-020
Primary DI / UDI-DI
08806369440714
Basic UDI-DI
B-08806369440714
EMDN Code
U0103 Urethral prostatic and bladder catheters with temperature sensors
Device Class
Class IIa
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
KR-MF-000019142
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Sewoon Medical Co., Ltd.

See all devices from Sewoon Medical Co., Ltd. →

Properties

  • Sterile
  • Measuring Function

Other properties (9)

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