BMEDIC ApS

Importer

🇩🇰 Denmark

Biotyx Medical (Shenzhen) Co.,Ltd.

Manufacturer

🇨🇳 China

GenSure Biotech Inc.

Manufacturer

🇨🇳 China

Respironics Inc.

Manufacturer

🇺🇸 United States·237 Basic UDI-DIs·285 Devices·TÜV SÜD Product Service GmbH and TÜV SÜD Product Service GmbH

Philips Medical Systems

Manufacturer

🇺🇸 United States·17 Basic UDI-DIs·41 Devices

Invivo, a division of Philips Medical Systems

Manufacturer

🇺🇸 United States·22 Basic UDI-DIs·67 Devices·INTERTEK SEMKO AB

Pro-Tech Services, Inc.

Manufacturer

🇺🇸 United States·2 Importers

Philips Medical Systems

Manufacturer

🇺🇸 United States·93 Basic UDI-DIs·211 Devices·TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH

Shenzhen Lifetech Cardio Medical Electronics Co.,Ltd.

Manufacturer

🇨🇳 China·1 Basic UDI-DI·1 Device·1 Importer·BSI Group The Netherlands B.V.

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INSYNC III MODEL 8042 AND INSYNC III MODEL 9981 APPLICATION SOFTWARE

Blood refrigerator/incubator

Basic UDI-DI

EU MDR · Eu Md Class 2a ·B Medical Systems S.à r.l.·1 device

Vaccine Transport Boxes

Basic UDI-DI

EU MDR · Eu Md Class 1 ·B Medical Systems S.à r.l.·6 devices

Laboratory Freezers

Basic UDI-DI

EU MDR · Eu Md Class 1 ·B Medical Systems S.à r.l.·11 devices

Ice-lined blood storage refrigerators

Basic UDI-DI

EU MDR · Eu Md Class 2a ·B Medical Systems S.à r.l.·2 devices

Plasma storage freezers

Basic UDI-DI

EU MDR · Eu Md Class 2a ·B Medical Systems S.à r.l.·11 devices

Pharmacy Refrigerator/Freezer

Basic UDI-DI

EU MDR · Eu Md Class 1 ·B Medical Systems S.à r.l.·1 device

Laboratory refrigerator/freezer

Basic UDI-DI

EU MDR · Eu Md Class 1 ·B Medical Systems S.à r.l.·1 device

Contact Shock Freezer

Basic UDI-DI

EU MDR · Eu Md Class 2a ·B Medical Systems S.à r.l.·6 devices

Blood bank refrigerators

Basic UDI-DI

EU MDR · Eu Md Class 2a ·B Medical Systems S.à r.l.·8 devices

Laboratory refrigerators

Basic UDI-DI

EU MDR · Eu Md Class 1 ·B Medical Systems S.à r.l.·8 devices