Eu Ivdd Eu Ivd Annex 2 List B On The Market ๐Ÿ‡จ๐Ÿ‡ณ China

Safe AQ UG

Changsha Sinocare Inc. ยท ๐Ÿ‡จ๐Ÿ‡ณ China
Devices (same UDI-DI)
1
Certificates
1
Countries
3
Notified Bodies
1

Basic Information

Primary DI
06934175026777
Basic UDI-DI Code
B-06934175026777
Reference
1V001DD
Device Types
None provided
Regulation
Eu Ivdd
Classification
Eu Ivd Annex 2 List B
Status
On The Market
Manufacturer
Changsha Sinocare Inc.

Additional Description

The Safe AQ UG Blood Glucose and Uric Acid Monitoring System is designed for the quantitative measurement of glucose and uric acid in fresh capillary whole blood samples and in venous whole blood samples. The Safe AQ UG Blood Glucose and Uric Acid Monitoring System is for use outside the body only (in vitro diagnostic use) for self-testing and professional use as an aid in the management of diabetes and hyperuricemia (HUA). The Safe AQ UG Blood Glucose and Uric Acid Monitoring System is intended for in vitrodiagnostic use and should not be used for the diagnosis of or screening of diabetes and hyperuricemia (HUA).

CND Nomenclature Codes

Code Description
W0201069099 VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER

Certificates

Type Number
IVDD Annex IV (excluding sections 4, 6) No. V1 060250 0017

Available In Countries

๐Ÿ‡ฉ๐Ÿ‡ช Germany ๐Ÿ‡ช๐Ÿ‡ธ Spain ๐Ÿ‡ฎ๐Ÿ‡น Italy

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