No Certificate Found

Snapshot 2026-10-12 · Link to EUDAMED

X4 Connect AFib (HEM-7196T1-FLEO)

UDI-DI 04015672114340Basic UDI-DI 4015672113925K

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

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Identification

Model: M7 Intelli IT AFib
EMDN: Z1203020302
Issuing agency: GS1
Device status: active
Sterile: No
Implantable: No
Measuring function: Yes
Reusable surgical: No

Certificates

No certificate found.

Snapshot 2026-10-12 · 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

M3 Comfort AFib (HEM-7196-FLE) 04015672114319
M4 Connect AFib (HEM-7196T1-FLE) 04015672114333
M6 Comfort AFib (HEM-7380-E) 04015672113978
M7 Intelli IT AFib (HEM-7380T1-EBK) 04015672113923
X3 Comfort AFib (HEM-7196-FLEO) 04015672114326
X7 Smart AFib (HEM-7380T1-EOSL) 04015672113930

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/x4-connect-afib-hem-7196t1-fleo-4340 · UDI page: /udi/04015672114340

All devices from OMRON Healthcare Co., Ltd.

Scan an inventory CSV