Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD), Healon® PRO, Healon GV® PRO, Healon5® PRO and Healon® Duet PRO

Driver Assy, Sleeve Nut, For Adv Spine (S9SPINE-CTL - Shukla Spine/ Universal Spinal Screw Removal System)

Device

EU MDR · Eu Md Class 1 ·S. S. White Technologies Inc/DBA Shukla Medical·On the market·4 countries

Chemtrue ®® COVID-19/Influenza A+B/RSV/ADV Antigen Combo Rapid Test (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shanghai Chemtron Biotech Co., Ltd.·On the market

FLUA-FLUB-RSV-ADV-COVID-19 Combo Test Device

Basic UDI-DI

EU IVDD · Eu Ivd General ·Assure Tech. (Hangzhou) Co., Ltd.·1 device

Tigsun Flu/RSV/AdV/PIV Combo Antigen Rapid Test

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Beijing Tigsun Diagnostics Co., Ltd.·9 devices

SARS-CoV-2 & Influenza A+B & RSV & ADV Antigen Combo Test Kit (Colloidal Gold)

Device

EU IVDR · Eu Ivd Class C ·ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD·On the market·11 countries

Silicone Penrose tube, Flat, OD:6 mm, L:300 mm

Basic UDI-DI

EU MDD · Eu Md Class 2a ·Besmed Health Business Corp.·1 device

Silicone Penrose tube, Round, OD:6 mm, L:500 mm

Basic UDI-DI

EU MDD · Eu Md Class 2a ·Besmed Health Business Corp.·1 device

Silicone Penrose tube, Round, OD:6 mm, L:300 mm

Basic UDI-DI

EU MDD · Eu Md Class 2a ·Besmed Health Business Corp.·1 device

Medichoice

FDA UDI

OWENS & MINOR DISTRIBUTION, INC.·10885632137303·Kit Driveline Management Includes Gloves Nitril...

SARS-CoV-2/Flu A+B/AdV/RSV Antigen Rapid Test

Basic UDI-DI

EU IVDD · Eu Ivd General ·Qingdao Hightop Biotech Co., Ltd.·1 device

Tigsun MP/CP/RSV/AdV/Cox B Combo IgM Rapid Test

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Beijing Tigsun Diagnostics Co., Ltd.·9 devices

Flu A Flu B+RSV+ ADV Rapid Detection Kit(Colloidal Gold)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Shenzhen Zijian Biotechnology Co., Ltd·1 device

NA

FDA UDI

BLACK DIAMOND VIDEO, INC.·00724995163723·The IDSS-SLC Version 8 OR Integration software ...

GlucoX GX1 Blood Glucose Plus ?-Ketone Monitoring System

FDA registration

TAIDOC TECHNOLOGY CORPORATION·4 products·🇹🇼 Taiwan

SARS-CoV-2 + FLU A/B + RSV+ ADV Combo Rapid Test Kit

Basic UDI-DI

EU IVDD · Eu Ivd General ·Vitrosens Biyoteknoloji Anonim Şirketi·1 device

Test, Ecarin Clotting Time (Ect)

FDA classification

Test, Ecarin Clotting Time (Ect)

Mycophenolic Acid Test System

FDA classification

FDA Class 2 ·Mycophenolic Acid Test System

SARS-CoV-2 + FLU A/B + RSV + ADV + Mycoplasma Combo Rapid Test Kit

Basic UDI-DI

EU IVDD · Eu Ivd General ·Vitrosens Biyoteknoloji Anonim Şirketi·1 device

SARS-CoV-2/FluA/FluB+ADV/RSV Antigen Combo Rapid Test Kit (LFIA)

Basic UDI-DI

EU IVDR · Eu Ivd Class D ·Jiangsu Medomics Medical Technology Co.,Ltd.·4 devices