8,122 results · 44ms · Sources: EU EUDAMED, US FDA

Visual, Pregnancy Hcg, Prescription Use

FDA classification
FDA Class 2 ·Visual, Pregnancy Hcg, Prescription Use

DCI DENTAL MALZEMELERİ VE TİCARET ANONİM ŞİRKETİ

Importer
🇹🇷 Türkiye

Zimmerman (Spectrophotometric), 17-Ketosteroids

FDA classification
FDA Class 1 ·Zimmerman (Spectrophotometric), 17-Ketosteroids

Analyzer, Gas, Nitrogen, Gaseous-Phase

FDA classification
FDA Class 2 ·Analyzer, Gas, Nitrogen, Gaseous-Phase

Lipase-Esterase, Enzymatic, Photometric, Lipase

FDA classification
FDA Class 1 ·Lipase-Esterase, Enzymatic, Photometric, Lipase

KCI Manufacturing Unlimited Company

Authorized representative
🇮🇪 Ireland·3 Manufacturers

Nettle

Basic UDI-DI
EU MDR · Eu Md Class 2a ·Samphire Neuroscience Ltd·1 device

Antisera, Hai, Parainfluenza Virus 1-4

FDA classification
FDA Class 1 ·Antisera, Hai, Parainfluenza Virus 1-4

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PAK/CALIBRATOR

NEPENTHES BENELUX

Importer
🇧🇪 Belgium·9 Manufacturers

Protective Barrier Enclosure With Negative Pressure

FDA classification
FDA Not Classified ·Protective Barrier Enclosure With Negative Pressure

Immunology

FDA registration
Diamond Diagnostics Inc.·10 products·🇭🇺 Hungary

VIDAS 3

FDA registration
BIOMERIEUX ITALIA-INDUSTRIAL DIV.·10 products·🇮🇹 Italy

Immunology

FDA registration
DIAMOND DIAGNOSTICS Inc·10 products·🇺🇸 United States

Protective Barrier Enclosure

FDA classification
FDA Not Classified ·Protective Barrier Enclosure

Antisera, Hai, Influenza Virus A, B, C

FDA classification
FDA Class 1 ·Antisera, Hai, Influenza Virus A, B, C

Kit, Test, Pregnancy, Hcg, Over The Counter

FDA classification
FDA Class 2 ·Kit, Test, Pregnancy, Hcg, Over The Counter

Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma

FDA classification
FDA Class 2 ·Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma

Remote Or Wearable Patient Monitoring Device For Drug Induced Qt Prolongation Monitoring

FDA classification
FDA Not Classified ·Remote Or Wearable Patient Monitoring Device For Drug Induced Qt Prolongation Monitoring

Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens

FDA classification
FDA Class 2 ·Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens