Establishment Registration & Device Listing

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Product Code : NIK

Establishment
Name

Registration Number

Current
Registration Yr

BENCHMARK ELECTRONICS, INC.

MN/USA

2133641

2013

defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) - 3650 Merlin Patient Care

Contract Manufacturer

BIOTRONIK AG

SWITZERLAND

8043892

2013

defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) - Dextrus; Selox; Setrox S; Tilda

Contract Manufacturer; Contract Sterilizer

BIOTRONIK SE & CO. KG

GERMANY

9610139

2013

defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) - CardioMessenger; Dextrus; Ecuro; EDP; Effecta; Estella; Evia; Evtovis; Home Monitoring; ICS 3000; Model 3145; Model 3150; Model 3171; Model 3175; Model 6646; Model 6652; Model 6653; P-KIT; PSW 1203.U/1; Reliaty; Renamic; Reocor; Selox; Setrox S; SLX; Solox; Tilda

Manufacturer

defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) - ICS 3000; PSW 1203.U/1; Renamic

Manufacturer

defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) - CardioMessenger; Celerity; Corox; Entovis HF(-T); Evia HF(-T); Home Monitoring; ICS 3000; LV-KIT; PSW 1203.U/1; Renamic; Stratos

Manufacturer

defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) - CardioMessenger; Home Monitoring; ICS 3000; Ilesto; Lumax; PSW 1203.U/1; Renamic

Manufacturer

BIOTRONIK, INC.

OR/USA

1028232

2013

defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) - CardioMessenger; Home Monitoring; ICS 3000; Lumax; PSW 1203.U/1; Renamic

Repackager/Relabeler

defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) - CardioMessenger; Dextrus; Ecuro; EDP; Effecta; Estella; Evia; Evtovis; Home Monitoring; ICS 3000; Model 3145; Model 3150; Model 3171; Model 3175; Model 6646; Model 6652; Model 6653; P-KIT; PSW 1203.U/1; Reliaty; Renamic; Reocor; Selox; Setrox S; Solox; Tilda

Repackager/Relabeler

defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) - ICS 3000; PSW 1203.U/1; Renamic

Repackager/Relabeler

defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) - CardioMessenger; Celerity; Corox; Entovis HF(-T); Evia HF(-T); Home Monitoring; ICS 3000; LV-KIT; PSW 1203.U/1; Renamic; Stratos

Repackager/Relabeler

Boston Scientific Corporation

PR/USA

2648729

2013

defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) - ACUITY Spiral; Bi Directional Torque Wrench; COGNIS; CONTAK CD; CONTAK CD Software Application; CONTAK CD2; CONTAK CD2 Software Application; CONTAK RENEWAL 3; CONTAK RENEWAL 3 AVT; CONTAK RENEWAL 3 AVT HE; CONTAK RENEWAL 3 HE; CONTAK RENEWAL 3 RF; CONTAK RENEWAL 3 RF HE; CONTAK RENEWAL AVT Software; CONTAK RENEWAL Software Application; EASYTRAK; EASYTRAK 2; EASYTRAK 2 IS-1; EASYTRAK 3; EASYTRAK 3 IS-1; ENERGEN CRT-D DF1/IS1; ENERGEN CRT-D IS4; Externals; Finishing Wire; INCEPTA CRT-D DF1/IS1; INCEPTA CRT-D DF1/LV1; INCEPTA CRT-D IS4; Lead Cap; Lead Stability Accessory (Suture Sleeve); LIVIAN RF1 HE; LIVIAN RF1 SE; PUNCTUA CRT-D DF1/IS1; PUNCTUA CRT-D IS4; Suture Sleeve

Manufacturer

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Establishment Registration & Device Listing

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