Establishment Registration & Device Listing

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Product Code : NKE

Establishment
Name

Registration Number

Current
Registration Yr

BENCHMARK ELECTRONICS, INC.

MN/USA

2133641

2013

pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p) - 3650 Merlin Patient Care

Contract Manufacturer

pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p) - 2067 RF Head; 2090TPS (2090/2090W Touch Pen Stylus); 2090W Carelink Programmer; 2090X Carelink Programmer; 2090XS0 (2090X Touch Pen Stylus); 2290 Lead Analyzer

Contract Manufacturer

BIOTRONIK AG

SWITZERLAND

8043892

2013

pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p) - Dextrus; Selox; Setrox S; Tilda

Contract Manufacturer; Contract Sterilizer

BIOTRONIK SE & CO. KG

GERMANY

9610139

2013

pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p) - 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

pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p) - ICS 3000; PSW 1203.U/1; Renamic

Manufacturer

pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p) - CardioMessenger; Celerity; Corox; Entovis HF(-T); Evia HF(-T); Home Monitoring; ICS 3000; LV-KIT; PSW 1203.U/1; Renamic; Stratos

Manufacturer

pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p) - CardioMessenger; Home Monitoring; ICS 3000; Ilesto; Lumax; PSW 1203.U/1; Renamic

Manufacturer

BIOTRONIK, INC.

OR/USA

1028232

2013

pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p) - CardioMessenger; Home Monitoring; ICS 3000; Lumax; PSW 1203.U/1; Renamic

Repackager/Relabeler

pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p) - 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

pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p) - ICS 3000; PSW 1203.U/1; Renamic

Repackager/Relabeler

pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p) - 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

IRELAND

9616693

2013

pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p) - CONTAK RENEWAL TR; CONTAK RENEWAL TR Software Application; Externals; INVIVE CRT-P IS-1; INVIVE CRT-P LV-1

Manufacturer

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Establishment Registration & Device Listing

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