TNP/MDR/0018/3830/2024

Certificate

MDR QMS·FOLDIX MEDICAL INŻ. UWE WERNER PETRASCH·TUV NORD Polska Sp. z o.o

MTIC_017-2019

Certificate

MDD Annex II Section 4·IDS LTD.·MTIC InterCert S.r.l.·1 Basic UDI-DI

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

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

Immunology

FDA registration

Diamond Diagnostics Inc.·10 products·🇭🇺 Hungary

VIDAS 3

FDA registration

BIOMERIEUX ITALIA-INDUSTRIAL DIV.·10 products·🇮🇹 Italy

Immunology

FDA registration

DIAMOND DIAGNOSTICS Inc·10 products·🇺🇸 United States

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.

Kid(z) & Co. Vertriebs-GmbH u. Co. KG

System producer

🇩🇪 Germany

BruxZir Shaded 16 PLUS Milling Blank D3 12mm Z

FDA registration

PRISMATIK DENTALCRAFT, INC.·1 product·🇺🇸 United States

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