FDA Registration
Active
🇨🇳 China
Amphenol Medical Technologies (Dongguan) Co., Ltd.
Reg #: 3013596024
·
FEI: 3013596024
·
Expires 2025
Products
7
Proprietary Names
0
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- Amphenol Medical Technologies (Dongguan) Co., Ltd.
- Registration Number
- 3013596024
- FEI Number
- 3013596024
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No.2, Xinhu Industrial Park, Qiaolong Road, Dengwu Village, Qiaotou
- City
- Dongguan Guangdong
- Country
- CN
Regulatory Submissions
- PMA Number
- P030054
Owner / Operator
- Firm Name
- Amphenol Critical Medical Technologies, LLC
- Operator Number
- 10053883
- Address
- 9586 Distribution Avenue, Suite F
- City
- San Diego
- State
- CA
- Postal Code
- 92121
- Country
- US
US Agent
- Business Name
- Amphenol Critical Medical Technologies, LLC
- Contact Name
- Lamont Rohde
- Address
- 9586 Distribution Avenue, Suite F
- City
- San Diego
- State
- CA
- ZIP
- 92121
- Country
- US
- [email protected]
- Phone
- 602 7503539
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) | NIK | Class 3 | Unknown | No | 2019-07-22 |
| Implantable Cardioverter Defibrillator (Non-Crt) | LWS | Class 3 | Unknown | No | 2019-07-22 |
| Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode | OJX | Class 3 | Unknown | No | 2019-07-22 |
| Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) | NKE | Class 3 | Unknown | No | 2019-07-22 |
| Pulse Generator, Permanent, Implantable | NVZ | Class 3 | Unknown | No | 2019-07-22 |
| Pacemaker/Icd/Crt Non-Implanted Components | OSR | Class 3 | Unknown | No | 2019-07-22 |
| Implantable Pulse Generator, Pacemaker (Non-Crt) | LWP | Class 3 | Unknown | No | 2019-07-22 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)