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

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC CONCERTO MODEL C154DWK ICD

Shandong Lianfa Medical Plastic Products Co.,Ltd.

Manufacturer

🇨🇳 China·11 Basic UDI-DIs·90 Devices·7 Importers·TÜV Rheinland LGA Products GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH

Andon Health Co., Ltd.

Manufacturer

🇨🇳 China·8 Basic UDI-DIs·11 Devices·7 Importers·TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, and TÜV Rheinland LGA Products GmbH

EVOLUTIS

Manufacturer

🇫🇷 France·11 Basic UDI-DIs·109 Devices·ITALCERT SRL, ITALCERT SRL, ITALCERT SRL, ITALCERT SRL, and ITALCERT SRL

BNC KOREA, Inc.

Manufacturer

🇰🇷 South Korea·60 Basic UDI-DIs·60 Devices·3EC International a.s., 3EC International a.s., and 3EC International a.s.

Shenzhen Kentro Medical Electronics CO.,LTD.

Manufacturer

🇨🇳 China·5 Basic UDI-DIs·16 Devices·2 Importers·Intertek Medical Notified Body AB, INTERTEK SEMKO AB, and INTERTEK SEMKO AB

ATENA LUX S.R.L.

Manufacturer

🇮🇹 Italy·30 Basic UDI-DIs·30 Devices·ITALCERT SRL, ITALCERT SRL, and ITALCERT SRL

Hamilton Bonaduz AG

Manufacturer

🇨🇭 Switzerland·92 Basic UDI-DIs·92 Devices·7 Importers·TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, and TÜV Rheinland LGA Products GmbH

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

FDA Pre-Market Approval

FDA Class 3 ·CONTAK RENEWAL 3 CRT-D MODELS H170/H175, CONTAK RENEWAL 3 HE CRT-D MODELS H177/H179, AND MODEL 2845 VERSION 2.2 SOFTWARE

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

FDA Pre-Market Approval

FDA Class 3 ·EPIC AND ATLAS+ HF CRT-D SYSTEMS

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

FDA Pre-Market Approval

FDA Class 3 ·CONTAK CD (MODEL 1823), CONTAK CD2 (MODEL H115, H119), RENEWAL (MODELS H135) AND RENEWAL 3 (MODELS H170,H175,H177,H179)

BETATEX SPA

Manufacturer

🇮🇹 Italy·9 Basic UDI-DIs·9 Devices·ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH

JIANGSU JIELE MEDICAL DRESSING CO.,LTD

Manufacturer

🇨🇳 China·12 Basic UDI-DIs·28 Devices·2 Importers·TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, and TÜV Rheinland LGA Products GmbH

Takagi seiko

Manufacturer

🇯🇵 Japan·14 Basic UDI-DIs·29 Devices·4 Importers·SGS Belgium NV, SGS FIMKO OY, SGS FIMKO OY, and SGS FIMKO OY

D1096300016

Certificate

MDD Annex V·Active Optical Systems Ltd·MDC MEDICAL DEVICE CERTIFICATION GMBH·2 Basic UDI-DIs

07290016727043

Certificate

MDD Annex V·Active Optical Systems Ltd·MDC MEDICAL DEVICE CERTIFICATION GMBH·1 Basic UDI-DI

13" ANT CL KNEE WRAP OP POP W/HINGE 3/16" XS

FDA registration

CORFLEX·1 product·🇺🇸 United States

13" ANT CL KNEE WRAP OP POP W/HINGE 3/16" XS

FDA registration

Corflex Caribe·1 product·🇩🇴 Dominican Republic

MedNet EC-REP IIb GmbH

Authorized representative

🇩🇪 Germany·32 Manufacturers·165 Devices

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

FDA Pre-Market Approval

FDA Class 3 ·CONTAK RENEWAL CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)