10,000 results · 406ms · Sources: EU EUDAMED, US FDA

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Tech Group Europe Limited t/a West

FDA registration
Tech Group Europe Limited t/a West·1 product·🇮🇪 Ireland

ABBOTT DIABETES CARE LIMITED

FDA registration
ABBOTT DIABETES CARE LIMITED·1 product·🇬🇧 United Kingdom

Procleix® HIV-1/HCV/HBV Quality Control

FDA registration
Grifols Diagnostic Solutions Inc.·1 product·🇺🇸 United States

Flextronics America, LLC

FDA registration
Flextronics America, LLC·1 product·🇺🇸 United States

FreeStyle Libre 2 Flash Glucose Monitoring System

FDA registration
Sanmina Ireland UC·1 product·🇮🇪 Ireland

ABBOTT DIABETES CARE INC.

FDA registration
ABBOTT DIABETES CARE INC.·1 product·🇺🇸 United States

ABBOTT DIABETES CARE LIMITED

FDA registration
ABBOTT DIABETES CARE LIMITED·1 product·🇬🇧 United Kingdom

ABBOTT DIABETES CARE INC.

FDA registration
ABBOTT DIABETES CARE INC.·1 product·🇺🇸 United States

REAL-TIME PCR INTERNAL CONTROL 2B SET

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Avant VR ICD, Avant DR ICD, Neutrino NxT VR ICD, Neutrino NxT DR ICD, Gallant VR ICD, Gallant DR ICD, Entrant VR ICD and

INDICAID™ HCG EARLY RESULT PREGNANCY TEST STRIP

FDA registration
Phase Scientific (Shenzhen) Company Limited·2 products·🇨🇳 China

HR HPV Master Mix

FDA registration
Phase Scientific (Shenzhen) Company Limited·1 product·🇨🇳 China

INDICAID COVID-19 Rapid Antigen Test

FDA registration
PHASE SCIENTIFIC INTERNATIONAL LIMITED·1 product·🇭🇰 Hong Kong

HR HPV Controls

FDA registration
Phase Scientific (Shenzhen) Company Limited·1 product·🇨🇳 China

INDICAID™ HCG EARLY RESULT PREGNANCY TEST STRIP

FDA registration
PHASE SCIENTIFIC INTERNATIONAL LIMITED·2 products·🇭🇰 Hong Kong

INDICAID Urine Collection Kit

FDA registration
Phase Scientific (Shenzhen) Company Limited·1 product·🇨🇳 China

INDICAID COVID-19 Rapid Antigen Test

FDA registration
Phase Scientific (Shenzhen) Company Limited·1 product·🇨🇳 China

Phasify Max Total DNA Extraction Kit

FDA registration
Phase Scientific (Shenzhen) Company Limited·1 product·🇨🇳 China

HR HPV Enzyme Mix

FDA registration
Phase Scientific (Shenzhen) Company Limited·1 product·🇨🇳 China

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval
FDA Class 3 ·Avant, Neutrino NxT, Gallant, Entrant, Unify, Unify Assura, Quadra Assura