Contract manufacturerEDAN Diagnostics, Inc. (San Diego, CA)CaliforniaAnesthesiologyCardiovascularGeneral hospitalNeurologyObstetrics and gynecologyRadiologyClass II
EDAN Diagnostics, Inc.
Contract manufacturer · San Diego, CA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3009499478 (openFDA record; or search FDA's registration database)
- FEI number
- 3009499478
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- EDAN Diagnostics, Inc. (FDA owner/operator no. 10043671)
- Registered address
- 9918 Via Pasar, San Diego, CA 92126
- Contract listings
- 24 device listings, 35 product codes, first listed Aug 13, 2025
- 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 |
|---|---|---|---|---|---|
| BZK | Spirometer, Monitoring (W/Wo Alarm) | Class II | Anesthesiology | Contract manufacturing | Dec 10, 2025 |
| BZQ | Monitor, Breathing Frequency | Class II | Anesthesiology | Contract manufacturing | Sep 4, 2025 |
| CBQ | Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | Class II | Anesthesiology | Contract manufacturing | Sep 4, 2025 |
| CBR | Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | Class II | Anesthesiology | Contract manufacturing | Sep 4, 2025 |
| CBS | Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | Class II | Anesthesiology | Contract manufacturing | Sep 4, 2025 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | Class II | Anesthesiology | Contract manufacturing | Sep 4, 2025 |
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | Class II | Anesthesiology | Contract manufacturing | Sep 4, 2025 |
| DPS | Electrocardiograph | Class II | Cardiovascular | Contract manufacturing | Sep 4, 2025 |
| DQA | Oximeter | Class II | Cardiovascular | Contract manufacturing | Aug 13, 2025 |
| DQK | Computer, Diagnostic, Programmable | Class II | Cardiovascular | Contract manufacturing | Sep 4, 2025 |
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | Class II | Cardiovascular | Contract manufacturing | Sep 4, 2025 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | Class II | Cardiovascular | Contract manufacturing | Sep 4, 2025 |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | Class II | Cardiovascular | Contract manufacturing | Dec 10, 2025 |
| DSB | Plethysmograph, Impedance | Class II | Cardiovascular | Contract manufacturing | Dec 10, 2025 |
| DSH | Recorder, Magnetic Tape, Medical | Class II | Cardiovascular | Contract manufacturing | Sep 4, 2025 |
| DSI | Detector And Alarm, Arrhythmia | Class II | Cardiovascular | Contract manufacturing | Sep 4, 2025 |
| DSK | Computer, Blood-Pressure | Class II | Cardiovascular | Contract manufacturing | Sep 4, 2025 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Class II | Cardiovascular | Contract manufacturing | Aug 13, 2025 |
| FLL | Continuous Measurement Thermometer | Class II | General hospital | Contract manufacturing | Aug 13, 2025 |
| GXY | Electrode, Cutaneous | Class II | Neurology | Contract manufacturing | Sep 4, 2025 |
| HEP | Monitor, Blood-Flow, Ultrasonic | Class II | Obstetrics and gynecology | Contract manufacturing | Sep 4, 2025 |
| HGL | Transducer, Ultrasonic, Obstetric | Class II | Obstetrics and gynecology | Contract manufacturing | Sep 4, 2025 |
| HGM | System, Monitoring, Perinatal | Class II | Obstetrics and gynecology | Contract manufacturing | Sep 4, 2025 |
| ITX | Transducer, Ultrasonic, Diagnostic | Class II | Radiology | Contract manufacturing | Sep 4, 2025 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Class II | Radiology | Contract manufacturing | Sep 4, 2025 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Class II | Radiology | Contract manufacturing | Sep 4, 2025 |
| KNG | Monitor, Ultrasonic, Fetal | Class II | Obstetrics and gynecology | Contract manufacturing | Sep 4, 2025 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | Class II | Cardiovascular | Contract manufacturing | Sep 4, 2025 |
| MLD | Monitor, St Segment With Alarm | Class II | Cardiovascular | Contract manufacturing | Sep 4, 2025 |
| MSX | System, Network And Communication, Physiological Monitors | Class II | Cardiovascular | Contract manufacturing | Sep 4, 2025 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | Class II | Cardiovascular | Contract manufacturing | Dec 10, 2025 |
| MWJ | Electrocardiograph, Ambulatory (Without Analysis) | Class II | Cardiovascular | Contract manufacturing | Sep 4, 2025 |
| NHO | Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) | Class II | Anesthesiology | Contract manufacturing | Sep 4, 2025 |
| NHP | Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) | Class II | Anesthesiology | Contract manufacturing | Sep 4, 2025 |
| NHQ | Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) | Class II | Anesthesiology | Contract manufacturing | Sep 4, 2025 |