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Shanghai MicroPort EP MedTech Co., Ltd.

Manufacturer
🇨🇳 China·12 Basic UDI-DIs·37 Devices·TÜV SÜD Product Service GmbH and TÜV SÜD Product Service GmbH

OptimAblate™ Irrigation Pump

Device
EU MDD · Eu Md Class 2a ·Shanghai MicroPort EP MedTech Co., Ltd.·On the market·6 countries

Columbus™ Reference Patch

Device
EU MDD · Eu Md Class 2a ·Shanghai MicroPort EP MedTech Co., Ltd.·On the market·5 countries

Columbus™ Cardiac Electrophysiology Stimulator

Device
EU MDD · Eu Md Class 2b ·Shanghai MicroPort EP MedTech Co., Ltd.·On the market·4 countries

OptimAblate™ Cardiac RF Generator

Device
EU MDD · Eu Md Class 2b ·Shanghai MicroPort EP MedTech Co., Ltd.·On the market·5 countries

OptimAblate™ Tubing Set

Basic UDI-DI
EU MDD · Eu Md Class 2a ·Shanghai MicroPort EP MedTech Co., Ltd.·1 device

Columbus™ Reference Patch

Basic UDI-DI
EU MDD · Eu Md Class 2a ·Shanghai MicroPort EP MedTech Co., Ltd.·1 device

Columbus™ Cardiac Electrophysiology Stimulator

Basic UDI-DI
EU MDD · Eu Md Class 2b ·Shanghai MicroPort EP MedTech Co., Ltd.·1 device

OptimAblate™ Cardiac RF Generator

Basic UDI-DI
EU MDD · Eu Md Class 2b ·Shanghai MicroPort EP MedTech Co., Ltd.·1 device

G1 081711 0023

Certificate
MDD Annex II (excluding section 4)·Shanghai MicroPort EP MedTech Co., Ltd.·TÜV SÜD Product Service GmbH·1 Basic UDI-DI

G1 081711 0023

Certificate
MDD Annex II (excluding section 4)·Shanghai MicroPort EP MedTech Co., Ltd.·TÜV SÜD Product Service GmbH·3 Basic UDI-DIs

MicroPort NeuroTech (Shanghai) Co.,Ltd.

Manufacturer
🇨🇳 China·402 Basic UDI-DIs·402 Devices·2 Importers·DQS Medizinprodukte GmbH, DQS Medizinprodukte GmbH, DQS Medizinprodukte GmbH, DQS Medizinprodukte GmbH, DQS Medizinprodukte GmbH, DQS Medizinprodukte GmbH, DQS Medizinprodukte GmbH, DQS Medizinprodukte GmbH, DQS Medizinprodukte GmbH, DQS Medizinprodukte GmbH, and DQS Medizinprodukte GmbH

Dongguan Kewei Medical Instrument Co., Ltd.

Manufacturer
🇨🇳 China·135 Basic UDI-DIs·135 Devices·1 Importer·BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., and BSI Group The Netherlands B.V.

Shanghai MicroPort Medical (Group) Co., Ltd.

Manufacturer
🇨🇳 China·350 Basic UDI-DIs·350 Devices·DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., and DEKRA Certification B.V.

544291 MRA

Certificate
MDD Annex II Section 4·MicroPort NeuroTech (Shanghai) Co.,Ltd.·DQS Medizinprodukte GmbH·347 Basic UDI-DIs

2141980DE04

Certificate
MDD Annex II Section 4·Shanghai MicroPort Medical (Group) Co., Ltd.·DEKRA Certification B.V.·132 Basic UDI-DIs

CE 623392

Certificate
MDD Annex II Section 4·Dongguan Kewei Medical Instrument Co., Ltd.·BSI Group The Netherlands B.V.·63 Basic UDI-DIs

CE 677889

Certificate
MDD Annex II Section 4·Dongguan Kewei Medical Instrument Co., Ltd.·BSI Group The Netherlands B.V.·13 Basic UDI-DIs

CE 677886

Certificate
MDD Annex II Section 4·Dongguan Kewei Medical Instrument Co., Ltd.·BSI Group The Netherlands B.V.·10 Basic UDI-DIs

CE 623391

Certificate
MDD Annex II Section 4·Dongguan Kewei Medical Instrument Co., Ltd.·BSI Group The Netherlands B.V.·49 Basic UDI-DIs