FDA Registration
Inactive
🇸🇬 Singapore
BIOTRONIK APM II PTE. LTD
·
Expires 2026
Products
11
Proprietary Names
29
Establishment Types
1
Classifications
11
Registration Details
- Registration Name
- BIOTRONIK APM II PTE. LTD
- Status
- Inactive
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 165 Kallang Way, #07-00 Mapletree Hi-Tech Park
- City
- Singapore South East
- Country
- SG
Owner / Operator
- Firm Name
- BIOTRONIK SE & CO. KG
- Operator Number
- 9018331
- Address
- 6024 Jean Road
- City
- Lake Oswego
- State
- OR
- Postal Code
- 97035
- Country
- US
US Agent
- Business Name
- BIOTRONIK Inc
- Contact Name
- Jon Brumbaugh
- Address
- 6024 Jean Road
- City
- Lake Oswego
- State
- OR
- ZIP
- 97035
- Country
- US
- [email protected]
- Phone
- 503 9707014
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pulse Generator, Permanent, Implantable | NVZ | Class 3 | Unknown | No | 2007-10-31 |
| Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) | NKE | Class 3 | Unknown | No | 2007-10-31 |
| Permanent Pacemaker Electrode | DTB | Class 3 | Cardiovascular | No | 2007-10-31 |
| Implantable Cardioverter Defibrillator (Non-Crt) | LWS | Class 3 | Unknown | No | 2007-10-31 |
| Pacemaker/Icd/Crt Non-Implanted Components | OSR | Class 3 | Unknown | No | 2007-10-31 |
| Pulse Generator, External Pacemaker, Dual Chamber | OVJ | Class 2 | Cardiovascular | No | 2007-10-31 |
| Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) | NIK | Class 3 | Unknown | No | 2007-10-31 |
| Programmer, Pacemaker | KRG | Class 3 | Cardiovascular | No | 2007-10-31 |
| Implantable Pacemaker Pulse-Generator | DXY | Class 3 | Cardiovascular | No | 2007-10-31 |
| Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes | NVN | Class 3 | Unknown | No | 2007-10-31 |
| Implantable Pulse Generator, Pacemaker (Non-Crt) | LWP | Class 3 | Unknown | No | 2007-10-31 |
Proprietary Names
Model 6653
EDP
Model 3150
Renamic
P-KIT
Estella
Model 3145
Dextrus
Reliaty
Reocor
Model 6652
Model 3171
Setrox S
Effecta
Model 6646
Evia
ICS 3000
Selox
Model 3175
Tilda
Solia T 53
Solia S 60
Solia CSP S 53
Solia JT 45
Solia CSP S 60
Solia S 45
Solia S 53
Solia T 60
Solia JT 53
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)