Eu Ivdd Eu Ivd Self Testing On The Market 🇩🇪 Germany

Atlas Home Diabetes test

Atlas Medical GmbH · 🇩🇪 Germany
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1

Basic Information

Primary DI
04260658550005
Basic UDI-DI Code
B-04260658550005
Reference
70004001
Device Types
Single use
Regulation
Eu Ivdd
Classification
Eu Ivd Self Testing
Status
On The Market
Manufacturer
Atlas Medical GmbH

Additional Description

The Atlas Diabetic Check kit contains dip-and-read test strips and is intended for use to check for glucose and ketones levels in urine specimens as an aid in diagnosing diabetes. The test provides results by the visual comparison with a colour chart printed on the pouch. Each colour denotes a range of concentrations of glucose and ketones.

CND Nomenclature Codes

Code Description
W0101060204 URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)

Certificates

Type Number
IVDD Annex III Section 6 16165

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