Establishment Registration & Device Listing

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Establishment
Name

Registration Number

Current
Registration Yr

Amphenol Medical Technologies (Dongguan) Co., Ltd.

CHINA

3013596024

2026

implantable pulse generator, pacemaker (non-crt)

Contract Manufacturer

BENCHMARK ELECTRONICS, INC.

MN/USA

2133641

2026

implantable pulse generator, pacemaker (non-crt)

Contract Manufacturer

implantable pulse generator, pacemaker (non-crt)

Contract Manufacturer

implantable pulse generator, pacemaker (non-crt)

Contract Manufacturer

implantable pulse generator, pacemaker (non-crt)

Contract Manufacturer

implantable pulse generator, pacemaker (non-crt)

Contract Manufacturer

Show all 6 Listings for BENCHMARK ELECTRONICS, INC. MN/USA

BIOTRONIK APM II PTE. LTD

SINGAPORE

No number listed

2026

implantable pulse generator, pacemaker (non-crt) - Dextrus; EDP; Effecta; Estella; Evia; ICS 3000; Model 3145; Model 3150; Model 3171; Model 3175; Model 6646; Model 6652; Model 6653; P-KIT; Reliaty; Renamic; Reocor; Selox; Setrox S; Solia CSP S 53; Solia CSP S 60; Solia JT 45; Solia JT 53; Solia S 45; Solia S 53; Solia S 60; Solia T 53; Solia T 60; Tilda

Contract Manufacturer

BIOTRONIK SE & CO. KG

GERMANY

9610139

2026

implantable pulse generator, pacemaker (non-crt) - Dextrus; EDP; Effecta; Estella; Evia; ICS 3000; Model 3145; Model 3150; Model 3171; Model 3175; Model 6646; Model 6652; Model 6653; P-KIT; Reliaty; Renamic; Reocor; Selox; Setrox S; Solia CSP S 53; Solia CSP S 60; Solia JT 45; Solia JT 53; Solia S 45; Solia S 53; Solia S 60; Solia T 53; Solia T 60; Tilda

Manufacturer

implantable pulse generator, pacemaker (non-crt) - S 60-J; S 60-K; S 60-S

Manufacturer

BIOTRONIK, INC.

OR/USA

1028232

2026

implantable pulse generator, pacemaker (non-crt) - Amvia; BS IS-1 Blind Plug; CardioMessenger; Dextrus; DH; Ecuro; Edora; EDP; Effecta; EFH; EFH-6F-W; Eluna; Entovis; Estella; Etrinsa; Evia; Evity; HMSC 3.55.0; HMSC Version 3.39; HMSC Version 3.40; HMSC Version 3.41; HMSC Version 3.42; HMSC Version 3.43; HMSC Version 3.44; HMSC Version 3.45; HMSC Version 3.47; HMSC Version 3.48; HMSC Version 3.53; HMSC Version 3.54; HMSC Version 3.57; HMSC Version 3.58; HMSC Version 3.60.0; HMSC Version 3.62; HMSC Version 3.63; HMSC Version 3.64; HMSC Version 3.64.1; HMSC Version 3.65; HMSC Version 3.65.1; Home Monitoring; ICS 3000; M-50 Magnet; Model 3145; Model 3150; Model 3171; Model 3175; Model 6646; Model 6652; Model 6653; NEO 2100.U; NEO 2201.U/1; NEO 2202.U; NEO 2204.U; NEO 2301.U; NEO 2302.U; NEO 2303.U; NEO 2401.U; NEO 2401.U/1; NK-29; P-KIT; PK-155; PK-155-B; PK-175; PK-222; PK-222-L ECG Cable; PK-83; PSW 1506.U; PSW 1506.U/1; PSW 1507.U; PSW 1702.U; PSW 1703.U; PSW 1704.U; PSW 1801.U; PSW 1804.U; PSW 1901.U; PSW 1904.U; PSW 2100.U; PSW 2100.U/1; PSW 2201.U/1; PSW 2202.U; PSW 2204.U; PSW 2301.U; PSW 2302.U; PSW 2303.U; PSW 2401.U; Reliaty; Renamic; Renamic Neo NEOexpress; Renamic Neo Programmer; Reocor; S 45; S 53; S 58; S 60; Safio; Selox; Setrox S; Solia; Solia CSP S 53; Solia CSP S 60; Solia T/JT; Solox; Solvia; Tilda

Repackager/Relabeler

implantable pulse generator, pacemaker (non-crt) - S 60

Repackager/Relabeler

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Establishment Registration & Device Listing

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