Contract manufacturerPhilips North America LLC (Export, PA)PennsylvaniaAnesthesiologyCardiovascularGeneral hospitalNeurologyObstetrics and gynecologyClass IIClass I
Philips North America LLC
Contract manufacturer ยท Export, PA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3016701404 (openFDA record; or search FDA's registration database)
- FEI number
- 3016701404
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer; Repackager or relabeler
- Owner or operator
- Philips Medical Systems International BV (FDA owner/operator no. 1217116)
- Registered address
- 1003 Corporate Lane, STE B, Export, PA 15632
- Contract listings
- 21 device listings, 38 product codes, first listed Mar 11, 2009
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| BZC | Calculator, Pulmonary Function Data | Class II | Anesthesiology | Contract manufacturing | Aug 23, 2023 |
| BZQ | Monitor, Breathing Frequency | Class II | Anesthesiology | Contract manufacturing | Jan 11, 2018 |
| CBQ | Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | Class II | Anesthesiology | Contract manufacturing | Aug 23, 2023 |
| CBR | Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | Class II | Anesthesiology | Contract manufacturing | Aug 23, 2023 |
| CBS | Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | Class II | Anesthesiology | Contract manufacturing | Aug 23, 2023 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | Class II | Anesthesiology | Contract manufacturing | Jan 11, 2018 |
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | Class II | Anesthesiology | Contract manufacturing | Aug 23, 2023 |
| DPS | Electrocardiograph | Class II | Cardiovascular | Contract manufacturing | Dec 14, 2022 |
| DQA | Oximeter | Class II | Cardiovascular | Contract manufacturing | Oct 17, 2017 |
| DQK | Computer, Diagnostic, Programmable | Class II | Cardiovascular | Contract manufacturing | Jul 10, 2012 |
| DRQ | Amplifier And Signal Conditioner, Transducer Signal | Class II | Cardiovascular | Contract manufacturing | Jan 11, 2018 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | Class II | Cardiovascular | Contract manufacturing | Oct 17, 2017 |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | Class II | Cardiovascular | Contract manufacturing | Jan 11, 2018 |
| DSF | Recorder, Paper Chart | Class I | Cardiovascular | Contract manufacturing | Aug 23, 2023 |
| DSH | Recorder, Magnetic Tape, Medical | Class II | Cardiovascular | Contract manufacturing | Oct 15, 2019 |
| DSI | Detector And Alarm, Arrhythmia | Class II | Cardiovascular | Contract manufacturing | Oct 17, 2017 |
| DSJ | Alarm, Blood-Pressure | Class II | Cardiovascular | Contract manufacturing | Oct 17, 2017 |
| DSK | Computer, Blood-Pressure | Class II | Cardiovascular | Contract manufacturing | Nov 19, 2018 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | Class II | Cardiovascular | Contract manufacturing | Jan 11, 2018 |
| DXJ | Display, Cathode-Ray Tube, Medical | Class II | Cardiovascular | Contract manufacturing | May 11, 2018 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Class II | Cardiovascular | Contract manufacturing | Oct 17, 2017 |
| FLL | Continuous Measurement Thermometer | Class II | General hospital | Contract manufacturing | Oct 17, 2017 |
| GWQ | Full-Montage Standard Electroencephalograph | Class II | Neurology | Contract manufacturing | Aug 23, 2023 |
| GWS | Analyzer, Spectrum, Electroencephalogram Signal | Class I | Neurology | Contract manufacturing | Aug 23, 2023 |
| HGM | System, Monitoring, Perinatal | Class II | Obstetrics and gynecology | Contract manufacturing | Nov 28, 2018 |
| KLK | Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia | Class II | Anesthesiology | Contract manufacturing | Aug 23, 2023 |
| KOI | Stimulator, Nerve, Peripheral, Electric | Class II | Anesthesiology | Contract manufacturing | Aug 23, 2023 |
| LKD | Monitor, Carbon-Dioxide, Cutaneous | Class II | Anesthesiology | Contract manufacturing | Aug 23, 2023 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | Class II | Cardiovascular | Contract manufacturing | Oct 17, 2017 |
| MLD | Monitor, St Segment With Alarm | Class II | Cardiovascular | Contract manufacturing | Oct 17, 2017 |
| MLO | Electrocardiograph, Ambulatory, With Analysis Algorithm | Class II | Cardiovascular | Contract manufacturing | Feb 18, 2016 |
| MSX | System, Network And Communication, Physiological Monitors | Class II | Cardiovascular | Contract manufacturing | Feb 26, 2016 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | Class II | Cardiovascular | Contract manufacturing | Jan 5, 2010 |
| MWJ | Electrocardiograph, Ambulatory (Without Analysis) | Class II | Cardiovascular | Contract manufacturing | Mar 11, 2009 |
| NHO | Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) | Class II | Anesthesiology | Contract manufacturing | Aug 23, 2023 |
| NHP | Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) | Class II | Anesthesiology | Contract manufacturing | Aug 23, 2023 |
| NHQ | Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) | Class II | Anesthesiology | Contract manufacturing | Aug 23, 2023 |
| OUG | Medical Device Data System | Class I | General hospital | Contract manufacturing | Oct 15, 2019 |