Reckitt Benckiser Healthcare (UK) Limited

Manufacturer

10 Importers·SGS Belgium NV and SGS Belgium NV

Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.

Manufacturer

🇨🇳 China·TÜV Rheinland LGA Products GmbH and TÜV Rheinland LGA Products GmbH

Sidam S.R.L.

Manufacturer

🇮🇹 Italy·TUV Rheinland Italia SRL and TUV Rheinland Italia SRL

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·ST JUDE MEDICAL EPIC HF SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

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

BIOTEC S.R.L.

Manufacturer

🇮🇹 Italy·17 Basic UDI-DIs·68 Devices·ITALCERT SRL and ITALCERT SRL

Koolcare Technology Co., Ltd.

Manufacturer

🇨🇳 China·9 Basic UDI-DIs·9 Devices·3 Importers·TÜV Rheinland LGA Products GmbH and TUV Rheinland Italia SRL

Ningbo HicRen Biotechnology Co., Ltd.

Manufacturer

🇨🇳 China·89 Basic UDI-DIs·89 Devices·TÜV Rheinland LGA Products GmbH and TÜV Rheinland LGA Products GmbH

Xiamen Compower Medical Tech. Co., Ltd.

Manufacturer

🇨🇳 China·68 Basic UDI-DIs·452 Devices·6 Importers·TÜV Rheinland LGA Products GmbH and TÜV SÜD Product Service GmbH

Zhuhai Seesheen Medical Technology Co., Ltd.

Manufacturer

🇨🇳 China·23 Basic UDI-DIs·44 Devices·3 Importers·TÜV Rheinland LGA Products GmbH and TÜV Rheinland LGA Products GmbH

Huma Therapeutics Limited

Manufacturer

1 Basic UDI-DI·1 Device·DQS Medizinprodukte GmbH and DQS Medizinprodukte GmbH

synedra information technologies GmbH

Manufacturer

🇦🇹 Austria·DQS Medizinprodukte GmbH and DQS Medizinprodukte GmbH

Beijing Target Medical Technologies Inc.

Manufacturer

🇨🇳 China·1 Importer·UDEM Adriatic d.o.o. and UDEM Adriatic d.o.o.

Noventure SL

Manufacturer

🇪🇸 Spain·ISTITUTO SUPERIORE DI SANITA' and ISTITUTO SUPERIORE DI SANITA'

IMMUCOR Medizinische Diagnostik GmbH

Manufacturer

🇩🇪 Germany·TÜV Rheinland LGA Products GmbH and TÜV Rheinland LGA Products GmbH

ShenZhen ZhengKang Technology Co., Ltd.

Manufacturer

🇨🇳 China·5 Basic UDI-DIs·8 Devices·TÜV Rheinland LGA Products GmbH and TÜV Rheinland LGA Products GmbH

Foshan COXO Medical Instrument Co., Ltd.

Manufacturer

🇨🇳 China·9 Basic UDI-DIs·9 Devices·8 Importers·TÜV Rheinland LGA Products GmbH and TÜV Rheinland LGA Products GmbH

Balt extrusion SAS

Manufacturer

🇫🇷 France·DQS Medizinprodukte GmbH and DQS Medizinprodukte GmbH

STERIFY S.R.L.

Manufacturer

🇮🇹 Italy·ITALCERT SRL and ITALCERT SRL

Huma Therapeutic Limited

Manufacturer

DQS Medizinprodukte GmbH and DQS Medizinprodukte GmbH