NOFACT VIII

FDA 510(k)

FDA Class 2 ·Hematology

True Speed Bucky

FDA UDI

CARESTREAM HEALTH, INC.·60889976573747·R30-17B-S BCKY1717W/SZESense

True Speed Bucky

FDA UDI

CARESTREAM HEALTH, INC.·60889976573754·R30-17B-S-T BCKY,SENS MDLw/ToshibaKalare

True Speed Bucky

FDA UDI

CARESTREAM HEALTH, INC.·60889976573730·R30-17B BUCKY: 17 X 17 RECIPROCATING

Haemochrom Diagnostica GmbH

Importer

🇩🇪 Germany·5 Manufacturers

Avant Medical

Importer

🇳🇱 Netherlands·12 Manufacturers

System, Test, Tumor Marker, For Detection Of Bladder Cancer

FDA Pre-Market Approval

FDA Class 3 ·ALERE NMP22 URINE COLLECTION KIT

Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

FDA classification

FDA Class 2 ·Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·Guardant360 CDx

mdi Europa GmbH

Authorized representative

🇩🇪 Germany·132 Manufacturers·4741 Devices

Medical Technology Promedt Consulting GmbH

Authorized representative

🇩🇪 Germany·194 Manufacturers·10009 Devices

Complement 4d (C4d) And Complement Receptor 1 (Cr1)

FDA classification

FDA Class 2 ·Complement 4d (C4d) And Complement Receptor 1 (Cr1)

Kingsmead Service B.V.

Authorized representative

🇳🇱 Netherlands·243 Manufacturers·2698 Devices

Emergo Europe B.V.

Authorized representative

🇳🇱 Netherlands·900 Manufacturers·22100 Devices

SUNGO Europe B.V.

Authorized representative

🇳🇱 Netherlands·1571 Manufacturers·20390 Devices