HbA1c Control Kit

Device name

HbA1c Control Kit

Basic UDI-DI

B-06938384631012

Device model

Level 1: 0.1 mL×3; Level 2: 0.1 mL×3

Issuing agency

EUDAMED

Version date

May 21, 2026

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Risk category

IVDD — General

Status

On the market

European Medical Device Nomenclature — the EU product classifications carried across this device family's references.

• W0101050205Diabetes controls