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S.A.L.F. S.p.A. Laboratorio Farmacologico

Manufacturer
🇮🇹 Italy·21 Basic UDI-DIs·202 Devices·ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', and ISTITUTO SUPERIORE DI SANITA'

MicroPort Orthopedics Inc.

Manufacturer
🇺🇸 United States·6 Basic UDI-DIs·75 Devices·3 Importers·ITALCERT SRL, ITALCERT SRL, ITALCERT SRL, and ITALCERT SRL

TatraMed Software s.r.o.

Manufacturer
🇸🇰 Slovakia·4 Basic UDI-DIs·6 Devices·3EC International a.s., 3EC International a.s., and 3EC International a.s.

GENSPEED Biotech

Manufacturer
🇦🇹 Austria·1 Basic UDI-DI·1 Device·QMD Services GmbH, QMD Services GmbH, QMD Services GmbH, and QMD Services GmbH

DEVINTEC SAGL

Manufacturer
🇨🇭 Switzerland·4 Basic UDI-DIs·16 Devices·5 Importers·BUREAU VERITAS ITALIA S.P.A., BUREAU VERITAS ITALIA S.P.A., ISTITUTO SUPERIORE DI SANITA', and BUREAU VERITAS ITALIA S.P.A.

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD

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

FDA Pre-Market Approval
FDA Class 3 ·EPIC + HF, ATLAS + HF, EPIC II + HF, ATLAS II + HF CARDIAC RESYNCHRONIZATION DEFIBRILLATORS

Elixir Medical Corporation

Manufacturer
🇺🇸 United States·2 Basic UDI-DIs·2 Devices·3 Importers·3EC International a.s., 3EC International a.s., and 3EC International a.s.

WOLF-Medizintechnik GmbH

Manufacturer
🇩🇪 Germany·8 Basic UDI-DIs·8 Devices·3EC International a.s., 3EC International a.s., and 3EC International a.s.

Medicap S.r.l

Manufacturer
🇮🇹 Italy·4 Basic UDI-DIs·5 Devices·ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', and ISTITUTO SUPERIORE DI SANITA'

Jiangsu Konsung Bio-Medical Science And Technology Co.,Ltd.

Manufacturer
🇨🇳 China·86 Basic UDI-DIs·107 Devices·5 Importers·TÜV Rheinland LGA Products GmbH, SGS Belgium NV, and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·VENTAK PRX AND MINI IMPLANTABLE CARDIOVERTER DEFIBRILLATORS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·VENTAK AV, PRIZM, VITALITY, VITALITY AVT IMPLANTABLE CARDIOVERTER DEFIBRILLATORS

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

FDA Pre-Market Approval
FDA Class 3 ·CONTAK CD AND RENEWAL CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS

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

FDA Pre-Market Approval
FDA Class 3 ·MODELS H115 AND H119 CONTAK CD 2 (CRT-D) CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR SYSTEM

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval
FDA Class 3 ·CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) DEVICES

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