FCL Science B.V.

Importer

🇳🇱 Netherlands

eZono AG

Authorized representative

🇩🇪 Germany·1 Manufacturer·1 Device

1434-MDD-365/2021

Certificate

MDD Annex II (excluding section 4)·FCU Co., Ltd.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI

HD 601442320001

Certificate

MDD Annex II (excluding section 4)·SCW Medicath Ltd.·TÜV Rheinland LGA Products GmbH·8 Basic UDI-DIs

HD601442320001

Certificate

MDD Annex II (excluding section 4)·SCW Medicath Ltd.·TÜV Rheinland LGA Products GmbH·3 Basic UDI-DIs

Forceps, Biopsy, Non-Electric, Reprocessed

FDA classification

FDA Class 1 ·Forceps, Biopsy, Non-Electric, Reprocessed

Copper Reduction, Glucose

FDA classification

FDA Class 2 ·Copper Reduction, Glucose

Laryngoscope, Rigid

FDA classification

FDA Class 1 ·Laryngoscope, Rigid

Fitting Software

Basic UDI-DI

EU MDR · Eu Md Class 2a ·SBO Hearing A/S·4 devices

Fitting Software

Basic UDI-DI

EU MDR · Eu Md Class 2a ·SBO Hearing A/S·10 devices

eZono AG

Importer

🇩🇪 Germany·2 Manufacturers

Endoscopic Magnetic Retriever, Exempt

FDA classification

FDA Class 2 ·Endoscopic Magnetic Retriever, Exempt

Medicor International NV/SA

Importer

🇧🇪 Belgium·3 Manufacturers

MICROFLOW-III IN SLEEVES W/SEP-COVER

FDA registration

Leica Biosystems Richmond, Inc.·1 product·🇺🇸 United States

Fc, Antigen, Antiserum, Control

FDA classification

FDA Class 1 ·Fc, Antigen, Antiserum, Control

Fc, Fitc, Antigen, Antiserum, Control

FDA classification

FDA Class 1 ·Fc, Fitc, Antigen, Antiserum, Control

Fc, Rhodamine, Antigen, Antiserum, Control

FDA classification

FDA Class 1 ·Fc, Rhodamine, Antigen, Antiserum, Control

France Chirurgie Instrumentation SAS (FCI S.A.S.)

System producer

🇫🇷 France

Igg (Fc Fragment Specific), Antigen, Antiserum, Control

FDA classification

FDA Class 1 ·Igg (Fc Fragment Specific), Antigen, Antiserum, Control

TEMO MEDICAL

Importer

🇫🇷 France·6 Manufacturers