Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·SOF-SENSOR GLUCOSE SENSORS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CARELINK MONITOR MODEL 2490G, CARDIOSIGHT READER MODEL 2020A, AND MODEL 2491 DDMA

SJJ Solutions B.V.

Importer

🇳🇱 Netherlands·3 Manufacturers

EEG Accessories

Basic UDI-DI

EU MDR · Eu Md Class 1 ·EB Neuro S.p.A.·1 device

BNS Family

Basic UDI-DI

EU MDR · Eu Md Class 2a ·EB Neuro S.p.A.·1 device

EEG Family

Basic UDI-DI

EU MDR · Eu Md Class 2b ·EB Neuro S.p.A.·1 device

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EVERA S DR, EVERA S VR, EVERA XT DR

2195-MED-2114204

Certificate

MDD Annex II (excluding section 4)·Nano Fanavaran Narin Teb·Szutest Uygunluk Değerlendirme A.Ş.·1 Basic UDI-DI

MRI system, accessory Risk Class I

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Esaote S.p.A.·11 devices

Medisol Technologies S.L.

Authorized representative

🇪🇸 Spain·1 Manufacturer·3 Devices

Health Tec srl

Authorized representative

🇮🇹 Italy·1 Manufacturer·4 Devices

Aktischicht & Adler GmbH

Authorized representative

🇩🇪 Germany·1 Manufacturer·2 Devices

663940 Immunochemistry Systems CAL 2 Calibrator 2

FDA registration

BECKMAN COULTER, INC.·7 products·🇺🇸 United States

663940 Immunochemistry Systems CAL 2 Calibrator 2

FDA registration

BECKMAN COULTER, INC.·7 products·🇺🇸 United States

NephroCan S.r.l.

Authorized representative

🇮🇹 Italy·4 Manufacturers

Alpha-2-Macroglobulin, Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Alpha-2-Macroglobulin, Antigen, Antiserum, Control

Accessories, Cleaning, For Endoscope

FDA classification

FDA Class 2 ·Accessories, Cleaning, For Endoscope

EBS medical

Importer

🇩🇰 Denmark

Chemistry Analyzer

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·2 devices

Glomin GmbH

Authorized representative

🇩🇪 Germany·6 Manufacturers·27 Devices