eKare inSight

FDA UDI

E-Kare Inc.·00860003459850·System for wound measurement and management.

E-Z BREATHERS

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

eKare Inc.

Manufacturer

🇺🇸 United States·2 Basic UDI-DIs·2 Devices

eKare inSight

FDA registration

EKARE INC.·1 product·🇺🇸 United States

inSight RM

FDA registration

EKARE INC.·1 product·🇺🇸 United States

eKare inSight

Device

EU MDR · Eu Md Class 1 ·eKare Inc.·On the market·15 countries

eKare inSight RM

Device

EU MDR · Eu Md Class 1 ·eKare Inc.·On the market·15 countries

AIM MANUFACTURING, LLC

FDA registration

AIM MANUFACTURING, LLC·1 product·🇺🇸 United States

AIM MANUFACTURING, LLC

FDA registration

AIM MANUFACTURING, LLC·1 product·🇺🇸 United States

eKare inSight RM

Basic UDI-DI

EU MDR · Eu Md Class 1 ·eKare Inc.·1 device

eKare inSight

Basic UDI-DI

EU MDR · Eu Md Class 1 ·eKare Inc.·1 device

Atlantico Systems, Ltd.

Authorized representative

🇮🇪 Ireland·10 Manufacturers·165 Devices

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·RESOLUTION ctDx FIRST

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne Liquid CDx (F1 Liquid CDx)

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·Guardant360 CDx

MedEnvoy Global BV

Authorized representative

🇳🇱 Netherlands·143 Manufacturers·2306 Devices

Advena Limited

Authorized representative

🇲🇹 Malta·467 Manufacturers·13717 Devices

MDSS GmbH

Authorized representative

🇩🇪 Germany·388 Manufacturers·16562 Devices

mdi Europa GmbH

Authorized representative

🇩🇪 Germany·132 Manufacturers·4741 Devices

Emergo Europe B.V.

Authorized representative

🇳🇱 Netherlands·900 Manufacturers·22100 Devices