3,874 results · 40ms · Sources: EU EUDAMED, US FDA

Mission HDL High Density Lipoprotein Test Devices

Basic UDI-DI
EU IVDD · Eu Ivd Self Testing ·Acon Biotech (Hangzhou) Co., Ltd.·1 device

QUIK-CHECK HDL High Density Lipoprotein Test Devices

Basic UDI-DI
EU IVDD · Eu Ivd Self Testing ·Acon Biotech (Hangzhou) Co., Ltd.·1 device

HDL UNION SRL

Importer
🇷🇴 Romania·4 Manufacturers

High Density Lipoprotein Cholesterol (HDL-C) Kit (Enzymatic Method)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Zybio Inc.·1 device

Blood Lipid Reagent Kit (TC/TG/HDL-C/LDL-C)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Changsha Sinocare Inc.·1 device

Thyroglobulin, Rhodamine, Antigen, Antiserum, Control

FDA classification
FDA Class 2 ·Thyroglobulin, Rhodamine, Antigen, Antiserum, Control

Berthelot Indophenol, Urea Nitrogen

FDA classification
FDA Class 2 ·Berthelot Indophenol, Urea Nitrogen

Safeguard Technologies Limited

Importer
🇮🇪 Ireland·3 Manufacturers

High-Density Lipoprotein Cholesterol (HDL-C) Assay Kit (Direct Method - Selective Inhibition Method)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Shenzhen AmTech Bioengineering Ltd., Inc.·1 device

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval
FDA Class 3 ·DIMENSION FPSA FLEX REAGENT CARTRIDGE

Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl

FDA classification
FDA Class 1 ·Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl

CE 663351

Certificate
MDD Annex II (excluding section 4)·EDL (Edition et Développement de Logiciels)·BSI Group The Netherlands B.V.·1 Basic UDI-DI

CE663351

Certificate
MDD Annex II (excluding section 4)·EDL (Edition et Développement de Logiciels)·BSI Group The Netherlands B.V.·1 Basic UDI-DI

ADL FARMACEUTICI SRL

System producer
🇮🇹 Italy

Lipoprotein, High Density, Hdl, Over The Counter

FDA classification
FDA Class 1 ·Lipoprotein, High Density, Hdl, Over The Counter

Eastimpex DL Kft.

Importer
🇭🇺 Hungary

LDL

Basic UDI-DI
EU IVDD · Eu Ivd General ·NS BIOTEC·1 device

D + L Dubois + Linke GmbH

Importer
🇩🇪 Germany

Anterior Spine Fixation System

Basic UDI-DI
EU MDD · Eu Md Class 2b ·Chongqing FWS Medical Device Co.,Ltd·1 device

Anterior Spine Fixation System

Basic UDI-DI
EU MDD · Eu Md Class 2b ·Chongqing FWS Medical Device Co.,Ltd·1 device