No Certificate Found

Snapshot 2026-10-09 · Link to EUDAMED

EK12

UDI-DI 00195278457547Basic UDI-DI 8406821BUG00415HD

Class IIa · MDR · GE Medical Systems Information Technologies, Inc.

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Identification

Model: Starting from V2
EMDN: Z12050392
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 Information Technologies, Inc.

SRN US-MF-000017529

US · Waukesha

manufacturer

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

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/ek12-7547 · UDI page: /udi/00195278457547

All devices from GE Medical Systems Information Technologies, Inc.

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