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UDI Compass
Certificate valid

Snapshot 2026-10-13 · Link to EUDAMED

mylife Control Solution GC550 Low + High

UDI-DI 04710949333331Basic UDI-DI 471094933BGM000018X

Class C · IVDR · Bionime Corporation

Identification
Model
GM550
Issuing agency
GS1
Device status
active
Sterile
No
Certificates

IX 2110160-1

EU technical documentation assessment · valid

Notified body: TÜV Rheinland LGA Products GmbH (0197)

Valid from 2026-07-23 · Expiry 2031-07-22

Scope not stated in certificate data.

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

Manufacturer

Bionime Corporation

SRN TW-MF-000008450

TW · Taichung City

manufacturer

Authorised representative: Emergo Europe B.V. (NL-AR-000000116)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/mylife-control-solution-gc550-low-high-3331 · UDI page: /udi/04710949333331

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