Stern Weber Polska sp. z o.o

System producer

🇵🇱 Poland

1434-MDD-149/2021

Certificate

MDD Annex II Section 4·RFBio Co., Ltd·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·3 Basic UDI-DIs

CeCert Sp. z o.o.

Notified body

🇵🇱 Poland·28 Manufacturers·47 Basic UDI-DIs

UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS TOTAL PROTEIN

FDA registration

DIAFARMA ECZA DEPOSU VE MEDIKAL DIS TICARET DIS TIC LTD STI·17 products·🇹🇷 Türkiye

467858 SYNCHRON Systems Albumin Reagent

FDA registration

BECKMAN COULTER, INC.·17 products·🇺🇸 United States

Atellica CH Vancomycin (Vanc)

FDA registration

Siemens Healthcare Diagnostics Inc.·17 products·🇺🇸 United States

467858 SYNCHRON Systems Albumin Reagent

FDA registration

Beckman Coulter Ireland Inc·17 products·🇮🇪 Ireland

Atellica CH Uric Acid (UA)

FDA registration

RANDOX LABORATORIES LIMITED·17 products·🇬🇧 United Kingdom

467858 SYNCHRON Systems Albumin Reagent

FDA registration

BECKMAN COULTER, INC.·17 products·🇺🇸 United States

Euromedical Srl

Importer

🇮🇹 Italy·12 Manufacturers

Paramedica Polska Sp. z o.o. Sp. k.

System producer

🇵🇱 Poland

TUV NORD Polska Sp. z o.o

Notified body

🇵🇱 Poland·55 Manufacturers·2498 Basic UDI-DIs

Dimension Vista GGT Flex

FDA registration

SIEMENS HEALTHCARE DIAGNOSTICS INC.·20 products·🇺🇸 United States

IlabU Sp. z o. o.

System producer

🇵🇱 Poland

IVD GROUP Sp. z o. o.

System producer

🇵🇱 Poland

Analyzer

FDA registration

Diamond Diagnostics Inc.·29 products·🇭🇺 Hungary

PROCLINIC SAU

Importer

🇪🇸 Spain·33 Manufacturers

VYTIL

Importer

🇫🇷 France·30 Manufacturers

Plandent Oy

Importer

🇫🇮 Finland·43 Manufacturers

COBAS INTEGRA SYSTEM

FDA registration

ROCHE DIAGNOSTICS GMBH·62 products·🇩🇪 Germany