ACEONEDENT KOREA INDUSTRIAL CO.

Manufacturer

🇰🇷 South Korea·81 Basic UDI-DIs·81 Devices·2 Importers·SGS Belgium NV, SGS Belgium NV, and SGS Belgium NV

APT Medical Inc.

Manufacturer

🇨🇳 China·46 Basic UDI-DIs·75 Devices·9 Importers·SGS Belgium NV, SGS Belgium NV, and SGS Belgium NV

Laboratoire Huckert's International

Manufacturer

🇧🇪 Belgium·25 Basic UDI-DIs·25 Devices·SGS Belgium NV, SGS Belgium NV, and SGS Belgium NV

Surgical Specialties Mexico S. DE R.L. DE C.V.

Manufacturer

🇲🇽 Mexico·297 Basic UDI-DIs·297 Devices·17 Importers·SGS Belgium NV, SGS Belgium NV, and SGS Belgium NV

STARmed Co., Ltd.

Manufacturer

🇰🇷 South Korea·392 Basic UDI-DIs·819 Devices·20 Importers·SGS Belgium NV, SGS Belgium NV, and SGS Belgium NV

Keeler Ltd

Manufacturer

42 Basic UDI-DIs·348 Devices·22 Importers·SGS Belgium NV, SGS Belgium NV, and SGS Belgium NV

La Brosse et Dupont

Manufacturer

🇫🇷 France·11 Basic UDI-DIs·34 Devices·SGS Belgium NV, SGS Belgium NV, and SGS Belgium NV

Nulatex Sdn. Bhd.

Manufacturer

🇲🇾 Malaysia·93 Basic UDI-DIs·97 Devices·2 Importers·SGS Belgium NV, SGS Belgium NV, and SGS Belgium NV

SAEYANG CO.,LTD.

Manufacturer

🇰🇷 South Korea·43 Basic UDI-DIs·43 Devices·2 Importers·SGS Belgium NV, SGS Belgium NV, and SGS Belgium NV

MF / SEWONMEDIX Inc.

Manufacturer

🇰🇷 South Korea·1286 Basic UDI-DIs·1678 Devices·SGS Belgium NV, SGS Belgium NV, and SGS Belgium NV

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·Biosense Webster Cables, EZ Steer Nav Catheter, NaviStar Catheter, NaviStar RMT Catheter

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·CELSIUS DS, NAVISTAR DS,NAVISTAR RMT DS, EZ STEER NAV DS CATHETERS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BIOSENSE WEBSTER CABLES, EZ STEER NAV CATHETER, NAVISTAR CATHETER, NAVISTAR RMT CATHETER

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR DS, CELSIUS DS, EZ STEER NAV DS, NAVISTAR RMT DS, CELSIUS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR/NAVISTAR RMT THERMOCOOL/EZ STEER THERMOCOOL/EZ STEER THERMOCOOL NAV CATHETERS

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·EZ Steer NAV DS Bi-Directional Electrophysiology Catheter, NAVISTAR DS Electrophysiology Catheter

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·EZ Steer ThermoCool Nav Catheter, EZ Steer ThermoCool Catheter, ThermoCool SmartTouch Catheters

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR CATHETER,NAVISTAR RMT CATHETER,EZ STEER NAV CATHETER,BIOSENSE WEBSTER CABLES

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·Biosense Webster Cables, EZ Steer Nav Catheter, NaviStar Catheter, NaviStar RMT Catheter

Behind The Ear Hearing Aid/TE-115F, TE-116F, TE-119F, TE-200F, TE-211F, TE-212F, TE-213F

FDA registration

ZHONGSHAN TIANLE HEARING TECHNOLOGY CO.,LTD·1 product·🇨🇳 China