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Snapshot 2026-10-11 · Link to EUDAMED

Legacy device

Bioptimal Silicone Foley Catheter

UDI-DI 08886483507654Basic UDI-DI B-08886483507654

Class IIa · MDD (legacy) · Bioptimal International PTE. LTD.

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Identification

Model: FC216W
EMDN: U020299
Issuing agency: GS1
Device status: active
Sterile: Yes
Implantable: No
Measuring function: No
Reusable surgical: No

Manufacturer

Bioptimal International PTE. LTD.

SRN SG-MF-000010306

SG · Singapore

manufacturer

Authorised representative: Shanghai International Holding Corp. GmbH(Europe) (DE-AR-000000001)

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/bioptimal-silicone-foley-catheter-7654 · UDI page: /udi/08886483507654

All devices from Bioptimal International PTE. LTD.

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