Panin Srl

Manufacturer

🇮🇹 Italy·8 Basic UDI-DIs·8 Devices·BUREAU VERITAS ITALIA S.P.A., ISTITUTO SUPERIORE DI SANITA', KIWA CERMET ITALIA S.P.A., and KIWA CERMET ITALIA S.P.A.

Jafron Biomedical Co., Ltd.

Manufacturer

🇨🇳 China·25 Basic UDI-DIs·49 Devices·4 Importers·TÜV Rheinland LGA Products GmbH, TÜV SÜD Product Service GmbH, TÜV Rheinland LGA Products GmbH, and TÜV Rheinland LGA Products GmbH

Vertex-Dental B.V.

Manufacturer

🇳🇱 Netherlands·30 Basic UDI-DIs·51 Devices·SGS Belgium NV, SGS Belgium NV, SGS Belgium NV, and SGS Belgium NV

STAT PROFILE

FDA UDI

NOVA BIOMEDICAL CORPORATION·00385480322041·Remanufactured Stat Profile pHOx Plus Analyzer

STAT PROFILE

FDA UDI

NOVA BIOMEDICAL CORPORATION·00385480498487·Stat Profile pHOx Plus Air Detector

STAT PROFILE

FDA UDI

NOVA BIOMEDICAL CORPORATION·00385480278072·STAT PROFILE pHOx PLUS SENSOR MODULE REPLACEMENT

STAT PROFILE

FDA UDI

NOVA BIOMEDICAL CORPORATION·00385480278034·Stat Profile pHOx Plus Analyzer

Eurolink Europe Compliance Limited

Authorized representative

🇮🇪 Ireland·35 Manufacturers·252 Devices

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

FDA Pre-Market Approval

FDA Class 3 ·CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL

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

FDA Pre-Market Approval

FDA Class 3 ·CONSULTA CRT-D & MAXIMO II CRT-D

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SECURA DR & MAXIMO II DR & SECURA VR & MAXIMO II VR

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC 2490C CARELINK MONITOR 2020A CARDIOSIGHT READER

Shanghai United Imaging Healthcare Co.,Ltd.

Manufacturer

🇨🇳 China·55 Basic UDI-DIs·55 Devices·1 Importer·TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH

S.E. Carburos Metálicos, S.A.

Manufacturer

🇪🇸 Spain·257 Basic UDI-DIs·257 Devices·SGS Belgium NV, CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS, CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS, DNV Product Assurance AS, and DNV Product Assurance AS

A.T.S. Applicazione Tecnologie Speciali s.r.l.

Manufacturer

🇮🇹 Italy·55 Basic UDI-DIs·55 Devices·TUV Rheinland Italia SRL, IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A., IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A., IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A., and IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.

Pulse-Generator, Single Chamber, Sensor Driven, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MICRONY PACEMAKERS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·META AND TEMPO PACEMAKERS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·PARAGON,PHOENIX, MULTILOG, AND SENSORITHM PACEMAKERS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·AURORA/QUADRA, REFLEX, SIMPLEX,META PACEMAKERS

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

FDA Pre-Market Approval

FDA Class 3 ·FRONTIER AND FRONTIER II BIVENTRICULAR PACING SYSTEMS