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Snapshot 2026-10-13 · Link to EUDAMED

Legacy device

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

UDI-DI 08806369403764Basic UDI-DI B-08806369403764

Class IIa · MDD (legacy) · SEWOON MEDICAL CO.,LTD.

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Identification

Model: 2105-014
EMDN: U0103
Issuing agency: GS1
Device status: active
Sterile: Yes
Implantable: No
Measuring function: Yes
Reusable surgical: No

Manufacturer

SEWOON MEDICAL CO.,LTD.

SRN KR-MF-000019142

KR · Cheonan-si, Chungcheongnam-do

manufacturer

Authorised representative: Obelis s.a. (BE-AR-000000106)

Related UDI-DIs

No other UDI-DIs share this Basic UDI-DI in this snapshot.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/sterile-single-use-all-silicone-foley-balloon-catheter-tempe-3764 · UDI page: /udi/08806369403764

All devices from SEWOON MEDICAL CO.,LTD.

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