4,572 results · 51ms · Sources: EU EUDAMED, US FDA

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval
FDA Class 3 ·SOLESTA INJECTABLE GEL

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK, CALIBRATOR, CONFIRMATORY KIT

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·AXSYM CORE 2.0 (LN 8B88)

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·VITROS ANTI-HBE ASSAY

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·VISTAKON SENOFILCON A BRAND CONTACT LENSES

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·VISTAKON (SENOFILCON A) CONTACT LENSES

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrator

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·Elecsys HBeAg

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·Elecsys HBcAg

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·VISTAKON (senofilcon A) Brand Contact Lenses

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval
FDA Class 3 ·Deflux Injectable Gel

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·PERMALENS EXTENDED WEAR CONTACT LENS

Aymed Medikal Teknoloji Sanayi ve Ticaret Limited Şirketi

Importer
🇹🇷 Türkiye

C-01-1080-682-19

Certificate
MDD Annex II (excluding section 4)·LM-Instruments Oy·Eurofins Electric & Electronics Finland Oy·64 Basic UDI-DIs

C-01-1080-682-19

Certificate
MDD Annex II (excluding section 4)·LM-Instruments Oy·Eurofins Electric & Electronics Finland Oy·1 Basic UDI-DI

Arthrone Oy

Importer
🇫🇮 Finland·7 Manufacturers

Medical Adhesive Tape

Basic UDI-DI
EU MDR · Eu Md Class 1 ·TRONJEN MEDICAL TECHNOLOGY INC.·3 devices

Wound Dressing

Basic UDI-DI
EU MDD · Eu Md Class 1 ·TRONJEN MEDICAL TECHNOLOGY INC.·1 device

Wound Dressing

Basic UDI-DI
EU MDD · Eu Md Class 1 ·TRONJEN MEDICAL TECHNOLOGY INC.·1 device

Wound Dressing

Basic UDI-DI
EU MDD · Eu Md Class 1 ·TRONJEN MEDICAL TECHNOLOGY INC.·1 device