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UDI Compass
Certificate valid

Snapshot 2026-10-11 · Link to EUDAMED

Hemonitor H1 Control Set

UDI-DI 08800076701205Basic UDI-DI 88000767HMCT001JN

Class B · IVDR · GenBody Inc.

Identification
Model
HMCT001
Issuing agency
GS1
Device status
active
Sterile
No
Certificates

IX 2631406-1

EU technical documentation assessment · valid

Notified body: TÜV Rheinland LGA Products GmbH (0197)

Valid from 2025-10-02 · Expiry 2030-10-01

Scope not stated in certificate data.

Certificate’s own scope text — not a compliance opinion from UDI Compass.

Manufacturer

GenBody Inc.

SRN KR-MF-000043626

KR · Seobuk-gu, Cheonan-si, Chungcheongnam-do

manufacturer

Authorised representative: Medical Technology Promedt Consulting GmbH (DE-AR-000000085)

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/hemonitor-h1-control-set-1205 · UDI page: /udi/08800076701205

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