CL 094011 0010 Rev. 00

Certificate

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

Sayan Tıbbi Aletler Paz. San. ve Tic. Ltd. Şti.

Authorized representative

🇹🇷 Türkiye

BruxZir Shaded 16 PLUS Milling Blank D3 12mm Z

FDA registration

PRISMATIK DENTALCRAFT, INC.·1 product·🇺🇸 United States

HAIRCLEAN

Importer

🇩🇪 Germany·5 Manufacturers

Melano GmbH

Importer

🇩🇪 Germany·7 Manufacturers

System, Balloon, Intra-Aortic And Control, Reprocessed

FDA classification

FDA Class 3 ·System, Balloon, Intra-Aortic And Control, Reprocessed

Catheter, Oximeter, Fiber Optic, Reprocessed

FDA classification

FDA Class 2 ·Catheter, Oximeter, Fiber Optic, Reprocessed

Trocar, Reprocessed

FDA classification

FDA Class 2 ·Trocar, Reprocessed

Bur, Diamond Coated, Reprocessed

FDA classification

FDA Class 1 ·Bur, Diamond Coated, Reprocessed

Biopsy Device, Percutaneous, Reprocessed

FDA classification

FDA Class 1 ·Biopsy Device, Percutaneous, Reprocessed

Needle And Needle Set, Gastro-Urology, Reprocessed

FDA classification

FDA Class 2 ·Needle And Needle Set, Gastro-Urology, Reprocessed

Needle, Biopsy, Cardiovascular, Reprocessed

FDA classification

FDA Class 1 ·Needle, Biopsy, Cardiovascular, Reprocessed

Catheter, Steerable, Reprocessed

FDA classification

FDA Class 2 ·Catheter, Steerable, Reprocessed

Needle, Dental, Reprocessed

FDA classification

FDA Class 1 ·Needle, Dental, Reprocessed

Needle, Aspiration And Needle, Reprocessed

FDA classification

FDA Class 1 ·Needle, Aspiration And Needle, Reprocessed

Needle, Hypodermic, Single Lumen, Reprocessed

FDA classification

FDA Class 2 ·Needle, Hypodermic, Single Lumen, Reprocessed

Needle, Gastro-Urology, Reprocessed

FDA classification

FDA Class 1 ·Needle, Gastro-Urology, Reprocessed

Injector And Syringe, Angiographic, Reprocessed

FDA classification

FDA Class 2 ·Injector And Syringe, Angiographic, Reprocessed

Set, Dialysis, Single Needle With Uni-Directional Pump, Reprocessed

FDA classification

FDA Class 2 ·Set, Dialysis, Single Needle With Uni-Directional Pump, Reprocessed

Actuator, Syringe, For Injector, Reprocessed

FDA classification

FDA Class 2 ·Actuator, Syringe, For Injector, Reprocessed