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UDI Compass
Certificate valid

Snapshot 2026-10-10 · Link to EUDAMED

Gmate® Blood Glucose Test Strip

UDI-DI 08809301168486Basic UDI-DI 880930116PS004AZ

Class C · IVDR · GB Lifecare Co., Ltd.

Identification
Model
PS-004
Issuing agency
GS1
Device status
active
Sterile
No
Certificates

IX 2061678-1

EU technical documentation assessment · valid

Notified body: TÜV Rheinland LGA Products GmbH (0197)

Valid from 2026-09-22 · Expiry 2031-09-21

Scope not stated in certificate data.

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

Manufacturer

GB Lifecare Co., Ltd.

SRN KR-MF-000039508

KR · Gunsan-si, Jeollabuk-do

manufacturer

Authorised representative: Obelis s.a. (BE-AR-000000106)

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/gmate-blood-glucose-test-strip-8486 · UDI page: /udi/08809301168486

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