HD 2062692-1

Certificate

MDD Annex II (excluding section 4)·Nexmed Technology Co.,Ltd.·TÜV Rheinland LGA Products GmbH·6 Basic UDI-DIs

HD 2062682-1

Certificate

MDD Annex II (excluding section 4)·Nexmed Technology Co.,Ltd.·TÜV SÜD Product Service GmbH·1 Basic UDI-DI

BYO-TECH SAS

Authorized representative

🇫🇷 France·1 Manufacturer·11 Devices

ACTIPROTECT UC N95 RESPIRATOR

FDA 510(k)

FDA Class 2 ·General Hospital

Scarmed Silicon Gel & Scarmed Plus Gel

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Sana Pharmaceutical Industry marketed by Sana Pharmaceutical Research Company·1 device

Device, Impotence, Mechanical/Hydraulic

FDA classification

FDA Class 3 ·Device, Impotence, Mechanical/Hydraulic

Prosthesis, Penis, Inflatable

FDA classification

FDA Class 3 ·Prosthesis, Penis, Inflatable

Mandibular Condyle Prosthesis

FDA classification

FDA Class 3 ·Mandibular Condyle Prosthesis

Wheelchair, Stair Climbing

FDA classification

FDA Class 2 ·Wheelchair, Stair Climbing

Diathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat

FDA classification

FDA Class 3 ·Diathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat

Spirometer, Therapeutic (Incentive)

FDA classification

FDA Class 2 ·Spirometer, Therapeutic (Incentive)

Absorber, Carbon-Dioxide

FDA classification

FDA Class 1 ·Absorber, Carbon-Dioxide

BYT Associates/Consult Medical

Authorized representative

🇪🇸 Spain

Stimulator, Neuromuscular, Implanted

FDA classification

FDA Class 3 ·Stimulator, Neuromuscular, Implanted

Stimulator, Vaginal, Muscle, Powered, For Therapeutic Use

FDA classification

FDA Class 3 ·Stimulator, Vaginal, Muscle, Powered, For Therapeutic Use

Implanted Diaphragmatic/Phrenic Nerve Stimulator

FDA classification

FDA Class 3 ·Implanted Diaphragmatic/Phrenic Nerve Stimulator

Stimulator, Intracerebral/Subcortical, Implanted

FDA classification

FDA Class 3 ·Stimulator, Intracerebral/Subcortical, Implanted

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA classification

FDA Class 3 ·Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

Teal Wand

FDA 510(k)

FDA Class 2 ·Microbiology

BRF SA ALKIMIAPHARMA

System producer

🇪🇸 Spain