CE-701506

Certificate

MDD Annex II (excluding section 4)·TTK HEALTHCARE LIMITED - PROTECTIVE DEVICES DIVISION·BSI Group The Netherlands B.V.·20 Basic UDI-DIs

434-MDD-406/2020

Certificate

MDD Annex II Section 4·TTK Healthcare Limited Heart Valve Division·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI

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

Reservoir, Blood, Cardiopulmonary Bypass, Exempt

FDA classification

FDA Class 2 ·Reservoir, Blood, Cardiopulmonary Bypass, Exempt

Leukemia DEK-CAN Fusion Gene  Real Time RT-PCR Kit

Basic UDI-DI

EU IVDD · Eu Ivd General ·SHANGHAI ZJ BIO-TECH CO., LTD·1 device

Cardiac Marker Multi Control

Basic UDI-DI

EU IVDR · Eu Ivd Class C ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·4 devices

Bureau Medica Intercert DK

Authorized representative

🇩🇰 Denmark·2 Manufacturers

Medex Instrumenten Service

Importer

🇳🇱 Netherlands·8 Manufacturers

Extender Drug-Released PTA 14 BTK Balloon Catheter, 4.0 mm Balloon diameter, 80mm Balloon lenght,120cm Catheter lenght

Basic UDI-DI

EU MDD · Eu Md Class 3 ·İNVAMED SAĞLIK İLAÇ SANAYİ VE TİCARET A.Ş.·1 device

Extender Drug-Released 14 BTK Balloon Catheter, 4.0 mm Balloon diameter, 30 mm Balloon lenght,150 cm Catheter lenght

Basic UDI-DI

EU MDD · Eu Md Class 3 ·İNVAMED SAĞLIK İLAÇ SANAYİ VE TİCARET A.Ş.·1 device

Extender Drug-Released 14 BTK Balloon Catheter, 3.5 mm Balloon diameter, 30 mm Balloon lenght,150 cm Catheter lenght

Basic UDI-DI

EU MDD · Eu Md Class 3 ·İNVAMED SAĞLIK İLAÇ SANAYİ VE TİCARET A.Ş.·1 device

Extender Drug-Released 14 BTK Balloon Catheter, 3.0 mm Balloon diameter, 30 mm Balloon lenght,150 cm Catheter lenght

Basic UDI-DI

EU MDD · Eu Md Class 3 ·İNVAMED SAĞLIK İLAÇ SANAYİ VE TİCARET A.Ş.·1 device

Extender Drug-Released 14 BTK Balloon Catheter, 2.75 mm Balloon diameter, 30 mm Balloon lenght,150 cm Catheter lenght

Basic UDI-DI

EU MDD · Eu Md Class 3 ·İNVAMED SAĞLIK İLAÇ SANAYİ VE TİCARET A.Ş.·1 device

Extender Drug-Released 14 BTK Balloon Catheter, 2.5 mm Balloon diameter, 30 mm Balloon lenght,150 cm Catheter lenght

Basic UDI-DI

EU MDD · Eu Md Class 3 ·İNVAMED SAĞLIK İLAÇ SANAYİ VE TİCARET A.Ş.·1 device

Extender Drug-Released 14 BTK Balloon Catheter, 2.0 mm Balloon diameter, 30 mm Balloon lenght,150 cm Catheter lenght

Basic UDI-DI

EU MDD · Eu Md Class 3 ·İNVAMED SAĞLIK İLAÇ SANAYİ VE TİCARET A.Ş.·1 device

Extender Drug-Released 14 BTK Balloon Catheter, 4.0 mm Balloon diameter, 26 mm Balloon lenght,150 cm Catheter lenght

Basic UDI-DI

EU MDD · Eu Md Class 3 ·İNVAMED SAĞLIK İLAÇ SANAYİ VE TİCARET A.Ş.·1 device

Extender Drug-Released 14 BTK Balloon Catheter, 3.5 mm Balloon diameter, 26 mm Balloon lenght,150 cm Catheter lenght

Basic UDI-DI

EU MDD · Eu Md Class 3 ·İNVAMED SAĞLIK İLAÇ SANAYİ VE TİCARET A.Ş.·1 device

Extender Drug-Released 14 BTK Balloon Catheter, 3.0 mm Balloon diameter, 26 mm Balloon lenght,150 cm Catheter lenght

Basic UDI-DI

EU MDD · Eu Md Class 3 ·İNVAMED SAĞLIK İLAÇ SANAYİ VE TİCARET A.Ş.·1 device