MedtechSourcebook

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 codeDevice (FDA name)ClassCategoryRoleFirst listed
BZKSpirometer, Monitoring (W/Wo Alarm)Class IIAnesthesiologyContract manufacturingDec 10, 2025
BZQMonitor, Breathing FrequencyClass IIAnesthesiologyContract manufacturingSep 4, 2025
CBQAnalyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)Class IIAnesthesiologyContract manufacturingSep 4, 2025
CBRAnalyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)Class IIAnesthesiologyContract manufacturingSep 4, 2025
CBSAnalyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)Class IIAnesthesiologyContract manufacturingSep 4, 2025
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseClass IIAnesthesiologyContract manufacturingSep 4, 2025
CCLAnalyzer, Gas, Oxygen, Gaseous-PhaseClass IIAnesthesiologyContract manufacturingSep 4, 2025
DPSElectrocardiographClass IICardiovascularContract manufacturingSep 4, 2025
DQAOximeterClass IICardiovascularContract manufacturingAug 13, 2025
DQKComputer, Diagnostic, ProgrammableClass IICardiovascularContract manufacturingSep 4, 2025
DRGTransmitters And Receivers, Physiological Signal, RadiofrequencyClass IICardiovascularContract manufacturingSep 4, 2025
DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)Class IICardiovascularContract manufacturingSep 4, 2025
DSACable, Transducer And Electrode, Patient, (Including Connector)Class IICardiovascularContract manufacturingDec 10, 2025
DSBPlethysmograph, ImpedanceClass IICardiovascularContract manufacturingDec 10, 2025
DSHRecorder, Magnetic Tape, MedicalClass IICardiovascularContract manufacturingSep 4, 2025
DSIDetector And Alarm, ArrhythmiaClass IICardiovascularContract manufacturingSep 4, 2025
DSKComputer, Blood-PressureClass IICardiovascularContract manufacturingSep 4, 2025
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveClass IICardiovascularContract manufacturingAug 13, 2025
FLLContinuous Measurement ThermometerClass IIGeneral hospitalContract manufacturingAug 13, 2025
GXYElectrode, CutaneousClass IINeurologyContract manufacturingSep 4, 2025
HEPMonitor, Blood-Flow, UltrasonicClass IIObstetrics and gynecologyContract manufacturingSep 4, 2025
HGLTransducer, Ultrasonic, ObstetricClass IIObstetrics and gynecologyContract manufacturingSep 4, 2025
HGMSystem, Monitoring, PerinatalClass IIObstetrics and gynecologyContract manufacturingSep 4, 2025
ITXTransducer, Ultrasonic, DiagnosticClass IIRadiologyContract manufacturingSep 4, 2025
IYNSystem, Imaging, Pulsed Doppler, UltrasonicClass IIRadiologyContract manufacturingSep 4, 2025
IYOSystem, Imaging, Pulsed Echo, UltrasonicClass IIRadiologyContract manufacturingSep 4, 2025
KNGMonitor, Ultrasonic, FetalClass IIObstetrics and gynecologyContract manufacturingSep 4, 2025
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Class IICardiovascularContract manufacturingSep 4, 2025
MLDMonitor, St Segment With AlarmClass IICardiovascularContract manufacturingSep 4, 2025
MSXSystem, Network And Communication, Physiological MonitorsClass IICardiovascularContract manufacturingSep 4, 2025
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Class IICardiovascularContract manufacturingDec 10, 2025
MWJElectrocardiograph, Ambulatory (Without Analysis)Class IICardiovascularContract manufacturingSep 4, 2025
NHOAnalyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)Class IIAnesthesiologyContract manufacturingSep 4, 2025
NHPAnalyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)Class IIAnesthesiologyContract manufacturingSep 4, 2025
NHQAnalyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)Class IIAnesthesiologyContract manufacturingSep 4, 2025