REGIUS CONSOLE CS-2000 AND REGIUS CONSOLE CS-3000, MEDICAL IMAGE PROCESSING WORKSTATION

FDA 510(k)

FDA Class 2 ·Radiology

Geo-Trade 2000 Kft.

Importer

🇭🇺 Hungary

BEO MedConsulting Berlin GmbH

Importer

🇩🇪 Germany

EKO Integrated Services Ltd.

Importer

🇮🇪 Ireland

C-01-1189-729-20

Certificate

MDD Annex II (excluding section 4)·Eko Health, Inc.·Eurofins Electric & Electronics Finland Oy·2 Basic UDI-DIs

KOO EUROPE

Authorized representative

🇮🇹 Italy·2 Manufacturers

STANDARD WHEELCHAIR STEELMAN EKO, SIZE 46 CM

Basic UDI-DI

EU MDR · Eu Md Class 1 ·UAB Kasko Group ·1 device

NO. G10864670010 Rev.02

Certificate

MDD Annex II (excluding section 4)·Leo Medical Co., Ltd.·TÜV SÜD Product Service GmbH·2 Basic UDI-DIs

FILTRYZER(TM)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NITRILE EXAMINATION GLOVES- PRE-POWDERED, SMALL, MEDIUM, AND LARGE

FDA 510(k)

FDA Class 1 ·General Hospital

FILTRYZER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NEO HEALTHIES LIMITED

Authorized representative

🇮🇪 Ireland·4 Manufacturers·9 Devices

Neo Medical GmbH

Authorized representative

🇩🇪 Germany·1 Manufacturer

Phosphomolybdate (Colorimetric), Inorganic Phosphorus

FDA classification

FDA Class 1 ·Phosphomolybdate (Colorimetric), Inorganic Phosphorus

Kappa, Fitc, Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Kappa, Fitc, Antigen, Antiserum, Control

No. G1 091024 0003

Certificate

MDD Annex II (excluding section 4)·Beijing KES Biology Technology Co.,Ltd.·TÜV SÜD Product Service GmbH·3 Basic UDI-DIs

G1 091024 0003

Certificate

MDD Annex II (excluding section 4)·Beijing KES Biology Technology Co.,Ltd.·TÜV SÜD Product Service GmbH·2 Basic UDI-DIs

G1 091024 0003

Certificate

MDD Annex II (excluding section 4)·Beijing KES Biology Technology Co.,Ltd.·TÜV SÜD Product Service GmbH·1 Basic UDI-DI

BEO MedConsulting Berlin GmbH

Authorized representative

🇩🇪 Germany·15 Manufacturers

Synermed IR500 Chemistry Analyzer IVD

FDA registration

Infrared Laboratory Systems dba SYNERMED·11 products·🇺🇸 United States