No Certificate Found

Snapshot 2026-10-09 · Link to EUDAMED

Caption Guidance

UDI-DI 00198953038604Basic UDI-DI 08406821BUG005477K

Class IIa · MDR · GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC

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Identification

Model: 5700645
EMDN: Z11040182
Issuing agency: GS1
Device status: active
Sterile: No
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

No certificate found.

Snapshot 2026-10-09 · Link to EUDAMED

Manufacturer

GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC

SRN US-MF-000016119

US · Waukesha

manufacturer

Authorised representative: GE Medical Systems SCS (FR-AR-000000344)

Related UDI-DIs

Caption AI 00198953030233

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/caption-guidance-8604 · UDI page: /udi/00198953038604

All devices from GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC

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