58 results · 142ms · Sources: EU EUDAMED, US FDA

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval
FDA Class 2 ·FLUOREX (TM) 600 (FLURSILFOCON A)

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval
FDA Class 2 ·FLUOREX(TM) RIGID GAS PERMEABLE CONTACT LENS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval
FDA Class 2 ·FLUOREX(TM) RIGID GAS PERMEABLE CONTACT LENS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval
FDA Class 2 ·FLUOREX(TM) FFLUSILFOCON) 700,500,300 RGP LENS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval
FDA Class 2 ·FLUOREX(TM) RIGID GAS PERMEABLE CONTACT LENS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval
FDA Class 2 ·FLUOREX (TM) 600 (FLURSILFOCON A)

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval
FDA Class 2 ·FLUOREX (TM) 600 (FLURSILFOCON A)

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval
FDA Class 2 ·FLUOREX (TM) 600 (FLURSILFOCON A)

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval
FDA Class 3 ·BREATH TEK UBT FOR H PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PHUR-CA)

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·PATHWAY ANTI-HER-2/NEU (4B5) PRIMARY ANTIBODY

SUNGO Europe B.V.

Authorized representative
🇳🇱 Netherlands·1571 Manufacturers·20390 Devices

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval
FDA Class 3 ·RESOLUTION ctDx FIRST

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval
FDA Class 3 ·Guardant360 CDx

Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

FDA classification
FDA Class 2 ·Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

Medical Technology Promedt Consulting GmbH

Authorized representative
🇩🇪 Germany·194 Manufacturers·10009 Devices

Emergo Europe B.V.

Authorized representative
🇳🇱 Netherlands·900 Manufacturers·22100 Devices

MedNet EC-REP GmbH

Authorized representative
🇩🇪 Germany·464 Manufacturers·5263 Devices

Kingsmead Service B.V.

Authorized representative
🇳🇱 Netherlands·243 Manufacturers·2698 Devices