Automatic Chemistry Analyzer

Device name

Automatic Chemistry Analyzer

Basic UDI-DI

6936895BS00326

Issuing agency

GS1

Version date

Oct 25, 2022

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Risk category

IVDR Class A

Status

On the market

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

• W0201010101Chemistry analysers - low routine (random access without ise mode test/h <= 400)
• W0201010102Chemistry analysers - moderate routine (random access without ise mode test/h > 400 and <= 800)
• W0201010103Chemistry analysers - moderate to high routine (random access without ise mode test/h > 800 and <= 1.200)
• W0201010104Chemistry analysers - high routine (random access without ise mode test/h > 1.200)
• W0201010107Chemistry analysers - moderate to high routine (with ise mode test/h > 800 and <= 1.200)