BE/2400000082

Certificate

IVDD Annex III Section 6·D-tek s.a.·SGS United Kingdom Limited·1 Basic UDI-DI

Meter, Peak Flow, Spirometry

FDA classification

FDA Class 2 ·Meter, Peak Flow, Spirometry

SNAP™

FDA UDI

KCI USA, INC.·00849554006041·Snap Therapy System Snap 100mmHg Therapy Cartri...

SIGNATURE PLANNER,

FDA registration

Zhejiang Biomet Medical Products Co., Ltd.·5 products·🇨🇳 China

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FDA registration

Materialise Sdn Bhd·5 products·🇲🇾 Malaysia

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FDA registration

Materialise Ukraine, Rep. office·5 products·🇺🇦 Ukraine

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FDA registration

Materialise USA, LLC.·5 products·🇺🇸 United States

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FDA registration

MATERIALISE N.V.·5 products·🇧🇪 Belgium

GEM 4000 PAK BG ISE GL COOX BILI 150 TEST 30 DAY

FDA UDI

INSTRUMENTATION LABORATORY COMPANY·08426950485728·GEM Premier 4000 pH, pCO2, pO2, Na+, K+, Ca++, ...

GEM Premier 7000 with iQM3 PAK (BG/ISE/COOX/Tbili 600 Tests)

FDA UDI

INSTRUMENTATION LABORATORY COMPANY·00195226000771·GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, N...

GEM Premier 7000 with iQM3 PAK (BG/ISE/COOX/Tbili 300 Tests)

FDA UDI

INSTRUMENTATION LABORATORY COMPANY·00195226000795·GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, N...

GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 75 Tests)

FDA UDI

INSTRUMENTATION LABORATORY COMPANY·00195226000665·GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, N...

GEM 4000 PAK BG ISE GL COOX BILI 600 TEST 21 DAY

FDA UDI

INSTRUMENTATION LABORATORY COMPANY·08426950485698·GEM Premier 4000 pH, pCO2, pO2, Na+, K+, Ca++, ...

GEM Premier 7000 with iQM3 PAK (BG/ISE/COOX/Tbili 150 Tests)

FDA UDI

INSTRUMENTATION LABORATORY COMPANY·00195226000801·GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, N...

GEM Premier 7000 with iQM3 PAK (BG/ISE/COOX/Tbili 75 Tests)

FDA UDI

INSTRUMENTATION LABORATORY COMPANY·00195226000818·GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, N...

GEM 4000 PAK BG ISE GL COOX BILI 450 TEST 30 DAY

FDA UDI

INSTRUMENTATION LABORATORY COMPANY·08426950485711·GEM Premier 4000 pH, pCO2, pO2, Na+, K+, Ca++, ...

GEM Premier 7000 with iQM3 PAK (7k BG/ISE/COOX 150 Tests)

FDA UDI

INSTRUMENTATION LABORATORY COMPANY·00195226000757·GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, N...

GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 150 Tests)

FDA UDI

INSTRUMENTATION LABORATORY COMPANY·00195226000658·GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, N...

GEM 4000 PAK BG ISE GL COOX BILI 300 TEST 30 DAY

FDA UDI

INSTRUMENTATION LABORATORY COMPANY·08426950481058·GEM Premier 4000 pH, pCO2, pO2, Na+, K+, Ca++, ...

GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 300 Tests)

FDA UDI

INSTRUMENTATION LABORATORY COMPANY·00195226000641·GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, N...