Lys Medical

System producer

🇧🇪 Belgium

SC EDY OPTIC LTT SRL

Importer

🇷🇴 Romania

Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Polymer Coated, Tested for Use with Chemotherapy Drugs; Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Polymer Coated, Tested for Use with Chemotherapy Drugs

FDA 510(k)

FDA Class 1 ·General Hospital

POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (COLORED)

FDA 510(k)

FDA Class 1 ·General Hospital

Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile

FDA 510(k)

FDA Class 1 ·General Hospital

Sterile Powder Free Nitrile Examination Glove, Blue Colored, with Non-Pyrogenic Labeling Claim, Sterile Powder Free Nitrile Examination Glove, White Colored, with Non-Pyrogenic Labeling Claim

FDA 510(k)

FDA Class 1 ·General Hospital

Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs, Powder Free Nitrile Patient Examination Glove, White Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs

FDA 510(k)

FDA Class 1 ·General Hospital

Powder Free Nitrile Examination Glove, Pink Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Orange Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Black Colored, Non-Sterile, Low Dermatitis

FDA 510(k)

FDA Class 1 ·General Hospital

Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile

FDA 510(k)

FDA Class 1 ·General Hospital

Sterile Latex Surgical Glove, Powder Free

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

Ventilator, External Body, Negative Pressure, Adult (Cuirass)

FDA classification

FDA Class 2 ·Ventilator, External Body, Negative Pressure, Adult (Cuirass)

Maintainer, Space Preformed, Orthodontic

FDA classification

FDA Class 1 ·Maintainer, Space Preformed, Orthodontic

BYT Associates/Consult Medical

Authorized representative

🇪🇸 Spain

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·LUMAX 300/340 & 500/540 DR/DR-T/VR/VR-T ICD'S, LUMAX 540 VR-T DX ICD, KRONOS LV-T, LUMAX 300/340 & 500/540 HF/HF-T CRT-D

Ldt, Approved By Nys Clep

FDA classification

FDA Not Classified ·Ldt, Approved By Nys Clep

2022/MDD

Certificate

MDD Annex II (excluding section 4)·Idrom LT S.L.·IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.·1 Basic UDI-DI

Ivd Offered As Ldt, Not An Ldt Or Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule

FDA classification

FDA Not Classified ·Ivd Offered As Ldt, Not An Ldt Or Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule

UAB “Davinci LT”

Importer

🇱🇹 Lithuania

Ldt, Not Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule

FDA classification

FDA Not Classified ·Ldt, Not Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule

ChestEye

Basic UDI-DI

EU MDD · Eu Md Class 2a ·Oxipit, UAB·1 device