FDA Registration
Active
🇲🇽 Mexico
Greatbatch Medical S. de R.L. de C.V.
Reg #: 3011823740
·
FEI: 3011823740
·
Expires 2026
Products
9
Proprietary Names
10
Establishment Types
1
Classifications
9
Registration Details
- Registration Name
- Greatbatch Medical S. de R.L. de C.V.
- Registration Number
- 3011823740
- FEI Number
- 3011823740
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Calle 5 Norte No. 511 Ciudad Industrial
- City
- Tijuana Baja California
- Country
- MX
Owner / Operator
- Firm Name
- GREATBATCH MEDICAL
- Operator Number
- 9035261
- Address
- 2300 Berkshire Lane N, --
- City
- Plymouth
- State
- MN
- Postal Code
- 55441
- Country
- US
US Agent
- Business Name
- Director Quality and Regulatory Affairs
- Contact Name
- Maria Mundaden
- Address
- 2300 Berkshire Ln N
- City
- Plymouth
- State
- MN
- ZIP
- 55441
- Country
- US
- [email protected]
- Phone
- 763 9518200
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrument, Ultrasonic Surgical | LFL | Class U | Unknown | No | 2014-12-23 |
| Automated External Defibrillators (Non-Wearable) | MKJ | Class 3 | Cardiovascular | No | 2021-01-04 |
| Dc-Defibrillator, Low-Energy, (Including Paddles) | LDD | Class 2 | Cardiovascular | No | 2014-12-23 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2016-09-28 |
| Ventricular (Assist) Bypass | DSQ | Class 3 | Unknown | No | 2014-12-23 |
| Over-The-Counter Automated External Defibrillator | NSA | Class 3 | Cardiovascular | No | 2021-01-04 |
| Implant, Auditory Brainstem | MHE | Class 3 | Unknown | No | 2024-11-26 |
| Implant, Cochlear | MCM | Class 3 | Unknown | No | 2024-11-26 |
| Implantable Pulse Generator | QFV | Class 3 | Unknown | No | 2019-05-28 |
Proprietary Names
CBC Charger
HeartStart FRx Defibrillator
HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL #M4735A
Battery Pack Li-ion for AR-600
HeartWare Ventricular Assist System
HeartStart FR3 Defibrillator
PHILIPS HEARTSTART FR2+ AUTOMATED EXTERNAL DEFIBRILLATOR
HeartStart OnSite Defibrillator
Nucleus® 24 Cochlear Implant System
HEARSTART MRX WITH AIRWAY CONFIMRATION ASSIST
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)