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UDI Compass

HeartGuide (HEM-6411T-MAE)

No Certificate Found

Snapshot 2026-10-31 · Link to EUDAMED

UDI-DI 04015672112056Basic UDI-DI 4015672112054R

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Class IIa · MDR · OMRON Healthcare Co., Ltd.

Identification

Model
HEM-6411T-MAE
Issuing agency
GS1
Device status
active
Sterile
No
Implantable
No
Measuring function
Yes
Reusable surgical
No

Certificates

No certificate found.

Snapshot 2026-10-31 · Link to EUDAMED

Manufacturer

OMRON Healthcare Co., Ltd.

SRN JP-MF-000007213

JP · Kyoto

manufacturer

Authorised representative: OMRON Healthcare Europe B.V. (NL-AR-000002683)

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/heartguide-hem-6411t-mae-2056 · UDI page: /udi/04015672112056

All devices from OMRON Healthcare Co., Ltd.