Gmate® Blood Glucose Test Strips

Trade Name

Gmate® Blood Glucose Test Strips

Gmate® Blood Glucose Test Strip

Model / Reference

PS-004, PS004-INT, PS-004-25-2

Primary DI / UDI-DI

08809301168486

Basic UDI-DI

B-08809301168486, 880930116PS004AZ

EMDN Code

W0201060102, W0101060101

Device Class

Class IVD Annex II List B

Class C

Market of Registration

Spain

Greece

EUDAMED SRN

KR-MF-000039508

Authorised representative

Obelis s.a. BE-AR-000000106

• Gmate® Plus Blood Glucose Test Strip

  Class C

  CE/IVDR

• Gmate® Origin Blood Glucose Monitoring System

  Class C

  CE/IVDR

• Gmate® Control Solution (Low)

  Class C

  CE/IVDR

• Gmate® Origin Blood Glucose Meter

  Class C

  CE/IVDR

• Gmate® Control Solution (Normal)

  Class C

  CE/IVDR IX 2061678-1 Active Valid to Sep 2031

• Gmate® Control Solution (High)

  Class C

  CE/IVDR IX 2061678-1 Active Valid to Sep 2031

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