Amphenol Alden Products Company
Registered establishment in Shenzhen, Guangdong, China. 24 device types.
Amphenol Alden Products Company is a contract manufacturer holding a current FDA establishment registration. The registration covers Cable, Electrode, Electrocardiograph and 22 other device types. Its earliest product listing with the FDA dates from 2008.
Registration
| Registered name | AMPHENOL ALDEN PRODUCTS COMPANY |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3012260771 |
| FEI number | 3012260771 |
| Establishment type | Contract manufacturer, Manufacturer |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | Building 1, No.7, Dongbao Road, |
| Postal code | 518106 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Aid, Cardiopulmonary Resuscitation | Class 2 | Agilent Pads Adapter Supplier Assy, MRx CBL Therapy Receptacle II 3ED, MRx CBL Pads With CPR Assist, Heartstream Pads Adapter Cable Assy | 2021 | 2 |
| Amplifier And Signal Conditioner, Transducer Signal | Class 2 | LABSYSTEM PRO, RF Filter Module for CLEARSIGN Amplifier, LABSYSTEM PRO, CLEARSIGN Amplifier to CARTO 3 System Quick Connect Intracardiac Cable, LABSYSTEM PRO, 40-Channel IC Junction Box for CLEARSIGN Amplifier, LABSYSTEM PRO, Stimulator Cable for CLEARSIGN Amplifier | 2020 | 4 |
| Analyzer, Pacemaker Generator Function | Class 2 | 2018 | 1 | |
| Automated External Defibrillators (Non-Wearable) | Class 3 | XL+ CBL External Paddle Assy, XL+ MECHASY Adapter Paddle Hybrid Electr, Agilent Pads Adapter Supplier Assy, MRx CBL Therapy Receptacle II 3ED, MRx CBL Pads With CPR Assist, Heartstream Pads Adapter Cable Assy | 2021 | 3 |
| Cable, Electrode | Class 2 | Cable, Electrode | 2016 | 47 |
| Cardiac Ablation Percutaneous Catheter | Class 3 | INTELLANAV Cable, Electrophysiology Cable Sterile Cable, Cable, IntellaTip MiFi XP | 2024 | 2 |
| Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation | Class 3 | IntellaNav StablePoint™ Cable | 2024 | 1 |
| Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter | Class 3 | IntellaNav StablePoint™ Cable, INTELLANAV Cable, Electrophysiology Cable Sterile Cable, Cable, IntellaTip MiFi XP | 2024 | 2 |
| Computer, Diagnostic, Programmable | Class 2 | EnSite™ X EP System IC Output Cable, EnSite™ X EP System ECG Cable, EnSite™ X EP System Recording System IC Output Cable, Ensite H700090, Rhythmia HDx 3m CardioLab Direct Connect ECG, Rhythmia HDx Patch Cable and 14 more | 2017 | 10 |
| Dc-Defibrillator, Low-Energy, (Including Paddles) | Class 2 | XL+ CBL External Paddle Assy, XL+ MECHASY Adapter Paddle Hybrid Electr, Agilent Pads Adapter Supplier Assy, MRx CBL Therapy Receptacle II 3ED, MRx CBL Pads With CPR Assist, Heartstream Pads Adapter Cable Assy and 1 more | 2021 | 3 |
| Device, Monitoring, Intracranial Pressure | Class 2 | Pulse Lok | 2008 | 5 |
| Device, Neurovascular Embolization | Class 2 | Izds Connecting Cable | 2015 | 5 |
| Device, Vascular, For Promoting Embolization | Class 2 | Izds Connecting Cable | 2025 | 6 |
| Electrocardiograph | Class 2 | Agilent Pads Adapter Supplier Assy, MRx CBL Therapy Receptacle II 3ED, MRx CBL Pads With CPR Assist, Heartstream Pads Adapter Cable Assy | 2021 | 18 |
| Electrosurgical, Cutting & Coagulation & Accessories | Class 2 | Codman Electrosurgical Interconnecting Cable, Da Vinci Monopolar and Bipolar Adapters | 2018 | 65 |
| Generator, Lesion, Radiofrequency | Class 2 | Cable Simplicity III TO Cosman RFG, 8 FT. Bipolar Reference Cable, Cable Neurotherm Electrode TO Cosman G4, Active Cable RED With Alligator Clip, Cable Cosman CSK FOR Baylis Multi-RFG, Adapter Cable Stryker RFG and 4 more | 2019 | 2 |
| Modular Electromechanical Surgical System | Class 2 | Bedside Unit Cable | 2026 | 1 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | Class 2 | Agilent Pads Adapter Supplier Assy, MRx CBL Therapy Receptacle II 3ED, MRx CBL Pads With CPR Assist, Heartstream Pads Adapter Cable Assy | 2021 | 17 |
| Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) | Class 2 | XL+ CBL External Paddle Assy, XL+ MECHASY Adapter Paddle Hybrid Electr, Agilent Pads Adapter Supplier Assy, MRx CBL Therapy Receptacle II 3ED, MRx CBL Pads With CPR Assist, Heartstream Pads Adapter Cable Assy | 2021 | 2 |
| Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation | Class 3 | FARASTAR Catheter Connection Cable, FARASTAR Gen 2 Catheter Connection Cable, Current™ PFA TactiSys™ Connect Cable (PFA-TSQ-CBL) | 2024 | 2 |
| Probe, Radiofrequency Lesion | Class 2 | Cable Cosman TCD FOR Neurotherm RFG, Adapter Plug Fortcd Electrode 3 Meter, Cable RF Injection Electrodes, Cosman TC Cable 8ft for Cosman TCD, 8 FT. Bipolar Reference Cable, Cable Neurotherm Electrode TO Cosman G4 and 7 more | 2019 | 1 |
| System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy | Class 3 | System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy | 2022 | 2 |
| System, Surgical, Computer Controlled Instrument | Class 2 | EnergyShield Monopolar Cautery Cord | 2021 | 4 |
| Transducer, Pressure, Catheter Tip | Class 2 | Comet, Pulse Lok | 2008 | 4 |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1929 |
|---|---|
| Main products | Medical cable assemblies, Precision connectors, Medical interconnect solutions |
| Certifications | FDA, ISO 13485 |
| Export markets | Global |
| OEM and ODM | Offered |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
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