867036, IntelliVue Multi-Measurement Module MMX

FDA registration

Philips Electronics Ltd·8 products·🇨🇦 Canada

IntelliVue Patient Monitor XG50 - 866063

FDA registration

Philips Electronics Ltd·8 products·🇨🇦 Canada

867036, IntelliVue Multi-Measurement Module MMX

FDA registration

Philips North America LLC·8 products·🇺🇸 United States

KR19/81826227

Certificate

MDD Annex II (excluding section 4)·MICRO-NX Co., Ltd.·SGS Belgium NV·18 Basic UDI-DIs

2195-MED-2031401

Certificate

MDD Annex V·MICRO-NX Co., Ltd.·Szutest Uygunluk Değerlendirme A.Ş.·5 Basic UDI-DIs

2195-MED-2031401

Certificate

MDD Annex V·MICRO-NX Co., Ltd.·Szutest Uygunluk Değerlendirme A.Ş.·3 Basic UDI-DIs

Genius 2

FDA UDI

Philips Medical Systems Hsg·00884838030497·

SureSigns VS2+

FDA UDI

Philips Medical Systems Hsg·00884838028401·SureSigns VS2+ NBP/SP02/Wireless

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHEK

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

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT IMX FREE PSA

Genius 2

FDA UDI

Philips Medical Systems Hsg·20884838028726·Genius 2 Probe Cover (CE marked)

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

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT ARCHITECT FREE PSA

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

FDA Pre-Market Approval

FDA Class 3 ·VIDAS FREE PSA RT ASSAY

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

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT AXSYM FREE PSA ASSAY

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

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE / IMMULITE 1000 AND IMMULITE 2000 FREE PSA ASSAYS

Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

FDA Pre-Market Approval

FDA Class 1 ·ABBOTT AXSYM TOTAL PSA ASSAY

uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)

FDA registration

Shenzhen Mindray Bio-Medical Electronics Co.,LTD·12 products·🇨🇳 China

uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)

FDA registration

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.·12 products·🇨🇳 China

P2psa

FDA Pre-Market Approval

FDA Class 3 ·ACCESS HYBRITECH P2PSA ON THE ACCESS IMMUNOASSAY SYSTEMS

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

FDA Pre-Market Approval

FDA Class 3 ·ACCESS HYBRITECH FREE PSA ON THE ACCESS 2 IMMUNOASSAY ANALYZER