17584

Certificate

MDD Annex II (excluding section 4)·EMED Technologies Corporation·GMED SAS·1 Basic UDI-DI

No. V1 097447 0006

Certificate

IVDD Annex IV (excluding sections 4, 6)·HMD Biomedical Inc.·TÜV SÜD Product Service GmbH·22 Basic UDI-DIs

No. V1 097447 0006

Certificate

IVDD Annex IV (excluding sections 4, 6)·HMD Biomedical Inc.·TÜV SÜD Product Service GmbH·6 Basic UDI-DIs

No. V1 097447 0006

Certificate

IVDD Annex IV (excluding sections 4, 6)·HMD Biomedical Inc.·TÜV SÜD Product Service GmbH·1 Basic UDI-DI

Care Orchestrator

FDA registration

RESPIRONICS INC.·8 products·🇺🇸 United States

Care Orchestrator

FDA registration

Philips Electronics Ltd·8 products·🇨🇦 Canada

Care Orchestrator

FDA registration

Philips India Limited - Sleep & Respiratory Care Business Unit·8 products·🇮🇳 India

2-ME solution for the differrentiation of IgM and IgG antibodies

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach·1 device

Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument

FDA 510(k)

FDA Class 2 ·Microbiology

PURITAN FOAM TIP SWAB MODEL 2197

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

VENTRESCREEN CAPILLARY BLOOD COLLECTION TUBE

FDA 510(k)

FDA Class 1 ·Hematology

Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit

FDA 510(k)

FDA Class 2 ·Microbiology

DOCUMENT THYROID CAL*VER

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

RYNEL MEDICAL FOAM

FDA 510(k)

FDA Class 1 ·General Hospital

DOCUMENT(TM) DIRECT ISE LINEARITY TEST SET

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

VISIONLINK ACR-NEMA CONVERSION UTILITIES

FDA 510(k)

FDA Class 1 ·Radiology

EPITECH ISLAND DRESSINGS

FDA 510(k)

FDA Class 1 ·General Hospital

SPQ TEST SYSTEM FOR C-REACTIVE PROTEIN

FDA 510(k)

FDA Class 2 ·Immunology

Multi Modality Viewer

FDA 510(k)

FDA Class 2 ·Radiology

VALIDATE THYROID CALIBRATION VERIFICATION TEST SET, MODEL 901

FDA 510(k)

FDA Class 1 ·Clinical Chemistry