FDA Registration
Active
🇲🇽 Mexico
AMPHENOL ALDEN PRODUCTS COMPANY
Reg #: 3007029079
·
FEI: 3007029079
·
Expires 2026
Products
23
Proprietary Names
53
Establishment Types
1
Classifications
23
Registration Details
- Registration Name
- AMPHENOL ALDEN PRODUCTS COMPANY
- Registration Number
- 3007029079
- FEI Number
- 3007029079
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Parque Industrial Dynatech, Ave. Severiano Talamante No. 6-B
- City
- Hermosillo Sonora
- Country
- MX
Owner / Operator
- Firm Name
- Amphenol Alden Products Company
- Operator Number
- 10025614
- Address
- 800 Technology Center Drive
- City
- Stoughton
- State
- MA
- Postal Code
- 02072
- Country
- US
- Correspondent
- Michael Virusso
US Agent
- Business Name
- Amphenol Alden Products
- Contact Name
- Michael Virusso
- Address
- 800 Technology Center Dr
- City
- Stoughton
- State
- MA
- ZIP
- 02072
- Country
- US
- [email protected]
- Phone
- 781 9531570
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Automated External Defibrillators (Non-Wearable) | MKJ | Class 3 | Cardiovascular | No | 2021-03-30 |
| Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) | DRO | Class 2 | Cardiovascular | No | 2021-03-30 |
| Dc-Defibrillator, Low-Energy, (Including Paddles) | LDD | Class 2 | Cardiovascular | No | 2021-03-30 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2024-08-22 |
| System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy | MEQ | Class 3 | Unknown | No | 2022-12-08 |
| Cable, Electrode | IKD | Class 2 | Physical Medicine | No | 2016-12-20 |
| Transducer, Pressure, Catheter Tip | DXO | Class 2 | Cardiovascular | No | 2008-04-24 |
| Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter | OAD | Class 3 | Unknown | No | 2024-05-03 |
| Cardiac Ablation Percutaneous Catheter | LPB | Class 3 | Unknown | No | 2024-05-03 |
| Device, Neurovascular Embolization | HCG | Class 2 | Neurology | No | 2025-11-24 |
| Device, Vascular, For Promoting Embolization | KRD | Class 2 | Cardiovascular | No | 2025-11-24 |
| Computer, Diagnostic, Programmable | DQK | Class 2 | Cardiovascular | No | 2017-03-28 |
| System, Surgical, Computer Controlled Instrument | NAY | Class 2 | Gastroenterology, Urology | No | 2021-05-11 |
| Generator, Lesion, Radiofrequency | GXD | Class 2 | Neurology | No | 2019-09-09 |
| Amplifier And Signal Conditioner, Transducer Signal | DRQ | Class 2 | Cardiovascular | No | 2020-01-23 |
| Device, Monitoring, Intracranial Pressure | GWM | Class 2 | Neurology | No | 2008-04-24 |
| Electrocardiograph | DPS | Class 2 | Cardiovascular | No | 2021-03-30 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2021-03-30 |
| Aid, Cardiopulmonary Resuscitation | LIX | Class 2 | Cardiovascular | No | 2021-03-30 |
| Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation | QZI | Class 3 | Unknown | No | 2024-02-01 |
| Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation | OAE | Class 3 | Unknown | No | 2024-02-28 |
| Probe, Radiofrequency Lesion | GXI | Class 2 | Neurology | No | 2019-09-09 |
| Modular Electromechanical Surgical System | SCV | Class 2 | General, Plastic Surgery | No | 2026-01-12 |
Proprietary Names
XL+ CBL External Paddle Assy
XL+ MECHASY Adapter Paddle Hybrid Electr
Da Vinci Monopolar and Bipolar Adapters
System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
CABLE, ELECTRODE
Pulse Lok
Internal Paddle Adapter Cable Assembly
INTELLANAV Cable
Electrophysiology Cable Sterile Cable
Cable, IntellaTip MiFi XP
IZDS CONNECTING CABLE
Rhythmia HDx 6m Clearsign Direct Connect Orion
Rhythmia HDx 3m CardioLab Direct Connect ECG
Rhytmia HDx 3m Clearsign Direct Connect ECG
Rhythmia HDx Patch Cable
Rhythmia HDx 3m Clearsign Direct Connect IC A/B
Rhythmia HDx Breakout Box Cable
Rhythmia HDx 6m CardioLab Direct Connect IC
Rhymia HDx 6m Clearsign Direct Connect ECG
Rhytmia HDx 3m Clearsign Direct Connect Orion
Rhythmia HDx 6m Clearsign Direct Connect IC A/B
Rhythmia HDX 3m CardioLab Direct Connect IC
EGM Out to SIgnal Station Cable -Stockert
Rhythimia HDx 6m CardioLab Direct Connect ECG
EGM Out to Signal Station Cable -IBI
EnergyShield Monopolar Cautery Cord
CABLE SIMPLICITY III TO COSMAN RFG
Codman Electrosurgical Interconnecting Cable
LABSYSTEM PRO, CLEARSIGN Amplifier to CARTO 3 System Quick Connect Intracardiac Cable
LABSYSTEM PRO, 40-Channel IC Junction Box for CLEARSIGN Amplifier
LABSYSTEM PRO, RF Filter Module for CLEARSIGN Amplifier
LABSYSTEM PRO, Stimulator Cable for CLEARSIGN Amplifier
Heartstream Pads Adapter Cable Assy
MRx CBL Therapy Receptacle II 3ED
MRx CBL Pads With CPR Assist
Agilent Pads Adapter Supplier Assy
FARASTAR Catheter Connection Cable
FARASTAR Gen 2 Catheter Connection Cable
IntellaNav StablePoint Cable
REFERENCE CABLE
8 FT. BIPOLAR REFERENCE CABLE
ACTIVE CABLE RED WITH ALLIGATOR CLIP
CABLE COSMAN CSK FOR BAYLIS MULTI-RFG
ADAPTER CABLE STRYKER RFG
CABLE NEUROTHERM RFG
TC Cable: 8 ft. for Cosman RFG
REF. CABLE WITH ALLIGATOR CLIP
CABLE NEUROTHERM ELECTRODE TO COSMAN G4
CABLE COSMAN TCD FOR NEUROTHERM RFG
ADAPTER PLUG FORTCD ELECTRODE 3 METER
Cosman TC Cable 8ft for Cosman TCD
CABLE RF INJECTION ELECTRODES
Bedside Unit Cable
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)