6,179 results · 38ms · Sources: EU EUDAMED, US FDA

RTX 3371

FDA 510(k)
FDA Class 2 ·Cardiovascular

Fibrinopeptide A, Antigen, Antiserum, Control

FDA classification
FDA Class 2 ·Fibrinopeptide A, Antigen, Antiserum, Control

Fc, Antigen, Antiserum, Control

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

Epic Den Bosch B.V.

Authorized representative
🇳🇱 Netherlands·1 Manufacturer·3 Devices

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·IDESIGN ADVANCED WAVESCAN STUDIO, STAR EXCIMER LASER SYSTEM

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·STAR S4 IR Excimer Laser System and iDESIGN Refractive Studio

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·STAR S4 IR EXCIMER LASER SYSTEM WITH IDESIGN WAVESCAN STUDIO SYSTEM

DRESSING KIT

Basic UDI-DI
EU MDR · Eu Md Class 1 ·JIANGSU YADA TECHNOLOGY GROUP CO., LTD·1 device

DRESSING KIT

Basic UDI-DI
EU MDR · Eu Md Class 1 ·JIANGSU YADA TECHNOLOGY GROUP CO., LTD·1 device

Dressing Kit

Basic UDI-DI
EU MDR · Eu Md Class 1 ·JIANGSU YADA TECHNOLOGY GROUP CO., LTD·1 device

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·STAR S4 IR Excimer Laser System and iDesign Advanced WaveScan Studio System

Powder-Free Polychloroprene Patient Examination Glove

FDA classification
FDA Class 1 ·Powder-Free Polychloroprene Patient Examination Glove

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·iDESIGNRefractive Studio, STAR Excimer Laser System

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) WAVESCAN WAVEFRONT SYSTEM

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS)

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·NIDEK EC-5000 EXCIMER LASER SYSTEM (PARK)

Surgeon'S Gloves

FDA classification
FDA Class 1 ·Surgeon'S Gloves

M.2025.MDR.1062 - 1

Certificate
MDR Technical Documentation·DK Medical Technology Co., Ltd.·UDEM Adriatic d.o.o.·1 Basic UDI-DI

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·ALLEGRETTO WAVE EYE-Q LASER SYSTEM