Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MAXIMO II DF-4 CRT-D, MAXIMO II DF-4 ICD, MAXIMO II ICD, PROTECTA DF4-ICD, PROTECTA ICD, PROTECTA XT DF-4 ICD, PROTECTA

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EVERA S DR/S VR ICD'S, EVERA XT DR/VR ICD'S, MAXIMO II ICD, PROTECTA/PROTECTA XT ICD'S; SECURA ICD, VIRTUOSO II DR/VR IC

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·BIO RAD MONOLISA ANTI-HBC IGM EIA

Savantini Ltd

Manufacturer

4 Basic UDI-DIs·14 Devices

Cumbre International Limited

Manufacturer

🇲🇾 Malaysia

Essential Dental Systems

Manufacturer

🇺🇸 United States·1 Importer

Helica Instruments Ltd

Manufacturer

1 Importer

Open Bionics Ltd.

Manufacturer

12 Basic UDI-DIs·12 Devices

Closed Loop Medicine Ltd.

Manufacturer

DName-iT Holdings Ltd

Manufacturer

1 Basic UDI-DI·1 Device

Enable Design Ltd

Manufacturer

2 Basic UDI-DIs·6 Devices

Predictive Health Intelligence Ltd

Manufacturer

1 Basic UDI-DI·1 Device

Rapidex Ltd

Manufacturer

1 Importer

Koalaa Ltd

Manufacturer

3 Basic UDI-DIs·80 Devices·1 Importer

Podonics Ltd

Manufacturer

OmniSeq, Inc. (LabCorp)

Manufacturer

🇺🇸 United States

Body Clock Health Care Limited

Manufacturer

1 Basic UDI-DI·9 Devices·2 Importers

Shenzhen Viatom Technolog Co, Ltd

Manufacturer

🇨🇳 China·30 Basic UDI-DIs·64 Devices·4 Importers·TÜV Rheinland LGA Products GmbH

Maxwell Glove Manufacturing Berhad

Manufacturer

🇲🇾 Malaysia·1 Basic UDI-DI·5 Devices

Supermax Glove Manufacturing Sdn Bhd

Manufacturer

🇲🇾 Malaysia·2 Basic UDI-DIs·16 Devices·5 Importers