FDA Registration
Active
🇹🇷 Türkiye
Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Reg #: 3015453963
·
FEI: 3015453963
·
Expires 2025
Products
6
Proprietary Names
1
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- CARDIMED ASIA MEDIKAL SANAYI VE TICARET LTD STI
- Registration Number
- 3015453963
- FEI Number
- 3015453963
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Cevizli Mah. Tansel Cad., No:12-18 Bulut Plaza D:32-33-34
- City
- Maltepe Istanbul
- Country
- TR
Regulatory Submissions
- PMA Number
- P010031
Owner / Operator
- Firm Name
- Cardimed Asia Medikal Sanayi ve Ticaret Ltd Sti
- Operator Number
- 10060492
- Address
- Cevizli Mah. Tansel Cad, No:12-18 Bulut Plaza D:32-33-34
- City
- Maltepe
- State
- Istanbul
- Postal Code
- 34846
- Country
- TR
US Agent
- Business Name
- ADVANCED INVENTORY INC
- Contact Name
- Jason Einhorn
- Address
- 9645 Willow Ln
- City
- Mokena
- State
- IL
- ZIP
- 60448
- Country
- US
- [email protected]
- Phone
- 888 4162409
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pacemaker/Icd/Crt Non-Implanted Components | OSR | Class 3 | Unknown | No | 2024-12-24 |
| Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) | NIK | Class 3 | Unknown | No | 2024-12-24 |
| Programmer, Pacemaker | KRG | Class 3 | Cardiovascular | No | 2024-12-24 |
| Implantable Cardioverter Defibrillator (Non-Crt) | LWS | Class 3 | Unknown | No | 2024-12-24 |
| Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) | NKE | Class 3 | Unknown | No | 2024-12-24 |
| Pulse Generator, Permanent, Implantable | NVZ | Class 3 | Unknown | No | 2024-12-24 |
Proprietary Names
Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Establishment Types
Export Device to the United States But Perform No Other Operation on Device