No Certificate Found

Snapshot 2026-10-12 · Link to EUDAMED

1.5T and 3.0T HD Breast Arrays

UDI-DI 00840682114394Basic UDI-DI 8406821BUG00359HU

Class I · MDR · GE Healthcare Coils

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Identification

Model: 1.5T and 3.0T HD Breast Arrays
EMDN: Z1105018001
Issuing agency: GS1
Device status: active
Sterile: No
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

No certificate found.

Snapshot 2026-10-12 · Link to EUDAMED

Manufacturer

GE Healthcare Coils

SRN US-MF-000001664

US · Aurora

manufacturer

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

Related UDI-DIs

1.5T HD FLAT GEM TABLE BREAST ARRAY 00840682115827
3.0T HD BREAST ARRAY 00840682103756
3.0T HD FLAT GEM TABLE BREAST ARRAY 00840682103763

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/1-5t-and-3-0t-hd-breast-arrays-4394 · UDI page: /udi/00840682114394

All devices from GE Healthcare Coils

Scan an inventory CSV