0068/QCO-DM/055-2018

Certificate

MDD Annex II Section 4·IDS LTD.·MTIC InterCert S.r.l.·3 Basic UDI-DIs

Rf Identification

FDA classification

FDA Not Classified ·Rf Identification

Antigen, Id, Candida Albicans

FDA classification

FDA Class 2 ·Antigen, Id, Candida Albicans

SMB EUROPE SAS

Authorized representative

🇫🇷 France·23 Manufacturers·42 Devices

DW Commerce GmbH

Authorized representative

🇩🇪 Germany

ALPHAMED LTD

Importer

3 Manufacturers

Candida Spp., Direct Antigen, Id

FDA classification

FDA Class 2 ·Candida Spp., Direct Antigen, Id

EC Certification Service GmbH

Authorized representative

🇦🇹 Austria·8 Manufacturers

Reprocessed Bronchoscope

FDA classification

FDA Class 2 ·Reprocessed Bronchoscope

Implantable Radio Frequency Transponder System

FDA classification

FDA Class 2 ·Implantable Radio Frequency Transponder System

Antigen, Cf And / Or Id, Coccidioides Immitis

FDA classification

FDA Class 2 ·Antigen, Cf And / Or Id, Coccidioides Immitis

Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.

FDA classification

FDA Class 2 ·Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.

System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection

FDA classification

FDA Class 2 ·System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection

ABALASE MEDICAL PRODUCTS LTD

Importer

18 Manufacturers

Obelis s.a.

Authorized representative

🇧🇪 Belgium·546 Manufacturers·18515 Devices