7,837 results
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47ms
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Sources: EU EUDAMED, US FDA
Roll Stand, OmniLab Advanced + - RIMR
FDA registration
CEVA LOGISTICS NETHERLANDS BV (Venray)·1 product·🇳🇱 Netherlands
Wisp SE Nasal Mask
FDA registration
CEVA LOGISTICS NETHERLANDS BV (Venray)·1 product·🇳🇱 Netherlands
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT CORE REAGENT KIT, ARCHITECT CORE CALIBRATOR AND ARCHITECT CORE CONTROLS
Edge™ Carbides FG 7406 Egg Gold Carbide Bur Clinic Pack
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172009492·Carbide dental bur, reusable
ACCURUN 130 Borrelia burgdorferi IgG Positive Control
Device
EU IVDD
·
Eu Ivd General
·LGC Clinical Diagnostics, Inc.·On the market
Rapid HAV IgG/IgM Combo Test Card
Device
EU IVDD
·
Eu Ivd General
·Xiamen Boson Biotech Co., Ltd.·On the market
Rapid Rickettsia IgG/IgM Combo Test Card
Device
EU IVDD
·
Eu Ivd General
·Xiamen Boson Biotech Co., Ltd.·On the market
Evo Autoimmune Control, b2-GPI IgG/IgM
Device
EU IVDR
·
Eu Ivd Class A
·ABD SRL·On the market·2 countries
Evo Autoimmune Control, AGA/tTG IgA/IgG
Device
EU IVDR
·
Eu Ivd Class A
·ABD SRL·On the market·2 countries
Evo Autoimmune Control, MPO/PR3/GBM IgG
Device
EU IVDR
·
Eu Ivd Class A
·ABD SRL·On the market·2 countries
Evo Autoimmune Control, DNA/HIS/NUC IgG
Device
EU IVDR
·
Eu Ivd Class A
·ABD SRL·On the market·2 countries
Evo Autoimmune Standard, anti-b2-GPI IgG
Device
EU IVDR
·
Eu Ivd Class A
·ABD SRL·On the market·2 countries
Sharay Anti-SS-B/La IgG (CLIA)
Device
EU IVDD
·
Eu Ivd General
·C-Luminary Biotechnology Co., Ltd.·No longer on the market
ACCURUN 25 ToRCH IgG Positive Control S2000
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·LGC Clinical Diagnostics, Inc.·On the market
ACCURUN 25 ToRCH IgG Positive Control S5000
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·LGC Clinical Diagnostics, Inc.·On the market
Rapid Dengue IgG/IgM Combo Test Card
Device
EU IVDD
·
Eu Ivd General
·Xiamen Boson Biotech Co., Ltd.·On the market
Herpes Simplex Virus 1+2 IgG（CLIA）
Device
EU IVDR
·
Eu Ivd Class C
·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·On the market·2 countries
Herpes Simplex Virus 1+2 IgG（CLIA）
Device
EU IVDR
·
Eu Ivd Class C
·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·On the market·2 countries
Herpes Simplex Virus 1+2 IgG（CLIA）
Device
EU IVDR
·
Eu Ivd Class C
·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·On the market·2 countries
Herpes Simplex Virus 1+2 IgG（CLIA）
Device
EU IVDR
·
Eu Ivd Class C
·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·On the market·2 countries