FDA Registration Active 🇨🇳 China

EDAN INSTRUMENTS, INC.

Reg #: 3003971136 · FEI: 3003971136 · Expires 2026
Products
55
Proprietary Names
134
Establishment Types
1
Classifications
54

Registration Details

Registration Name
EDAN INSTRUMENTS, INC.
Registration Number
3003971136
FEI Number
3003971136
Status
Active
Expiry Year
2026
Initial Importer
No
Address
#15 Jinhui Road, Jinsha Community, Kengzi Sub-District, Pingshan District
City
Shenzhen Guangdong
Country
CN

Regulatory Submissions

510(k) Number
K180380

Owner / Operator

Firm Name
EDAN INSTRUMENTS, INC.
Operator Number
9055347
Address
#15 Jinhui Road,Jinsha Community, Kengzi Sub-District, Pingshan District
City
Shenzhen
State
Guangdong
Postal Code
518122
Country
CN

US Agent

Business Name
Edan Diagnostics, Inc
Contact Name
Annie Wright
Address
9918 Via Pasar, San Diego CA
City
San Diego
State
CA
ZIP
92126
Country
US
Phone
408 4211510

Products

Device Name Product Code
Continuous Measurement Thermometer FLL
System, Measurement, Blood-Pressure, Non-Invasive DXN
Oximeter DQA
Electrocardiograph, Ambulatory (Without Analysis) MWJ
Recorder, Magnetic Tape, Medical DSH
Colposcope (And Colpomicroscope), Exempt PTZ
Cable, Transducer And Electrode, Patient, (Including Connector) DSA
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
Detector And Alarm, Arrhythmia DSI
Computer, Blood-Pressure DSK
Vectorcardiograph DYC
Electrocardiograph DPS
System, Imaging, Pulsed Doppler, Ultrasonic IYN
System, Imaging, Pulsed Echo, Ultrasonic IYO
Transducer, Ultrasonic, Diagnostic ITX
Treadmill, Powered IOL
Computer, Diagnostic, Programmable DQK
NSX
Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) CBS
Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) NHQ
Plethysmograph, Impedance DSB
Spirometer, Monitoring (W/Wo Alarm) BZK
Monitor, Breathing Frequency BZQ
Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) CBR
Transmitters And Receivers, Physiological Signal, Radiofrequency DRG
Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) CBQ
Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) NHO
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
Analyzer, Gas, Oxygen, Gaseous-Phase CCL
Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) NHP
Monitor, St Segment With Alarm MLD
Monitor, Ultrasonic, Fetal KNG
Flowmeter, Blood, Cardiovascular DPW
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
Recorder, Paper Chart DSF
Stimulator, Nerve, Transcutaneous, For Pain Relief GZJ
Stimulator, Muscle, Powered IPF
System, Monitoring, Perinatal HGM
Monitor, Uterine Contraction, External (For Use In Clinic) HFM
Transducer, Ultrasonic, Obstetric HGL
Alarm, Blood-Pressure DSJ
Transducer, Pressure, Intrauterine HFN
System, Network And Communication, Physiological Monitors MSX
Electrode, Cutaneous GXY
Electrode, Ion Specific, Calcium JFP
Calibrator, Multi-Analyte Mixture JIX
Electrode, Ion Specific, Sodium JGS
Instrument, Hematocrit, Automated GKF
Controls For Blood-Gases, (Assayed And Unassayed) JJS
Electrode, Ion-Specific, Chloride CGZ
Control, Hematocrit GLK
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph CHL
Electrode, Ion Specific, Potassium CEM
Monitor, Blood-Flow, Ultrasonic HEP

Proprietary Names

Vital Signs Monitor model iM3 Vital Signs Monitor model VSM Holter ECG and ABP system Model:SA-20;SA-19;SA-18;SA-16;SA-15 Video Colposcope, Models C6A HD, C3A, C6A Video Colposcope, models: C9 UHD, C12 UHD Video Colposcope, models: C9A UHD, C12A UHD Patient Monitor models iM8,iM8A,iM8B Patient Monitor models PM-2000A,PM-2000A+,PM-2000A Pro Patient Monitor model Waveline EZx Electrocardiograph Model: SE-1202 Diagnostic Ultrasound System, models: Acclarix AX4, Acclarix LX4 TM-400 Treadmill Vital signs monitor model MM3 Vital Signs Monitor models VSM-300,VSM-300A Vital signs monitor models M3, M3A Holter ECG and ABP system (Model: HolterABP) Diagnostic Ultrasound System, models: Acclarix AX8 , Acclarix AX7 Diagnostic Ultrasound System, model: Acclarix LX8 Smart ECG Net Ultrasonic Imaging Management System UMS 100 Data Management Software CMS-LITE Insight Smart ECG Viewer Oximeter Viewer Acclarix LX9 Series Diagnostic Ultrasound System Acclarix AX8, Acclarix AX7 Diagnostic Ultrasound System Patient Monitor LMPLUS-12, LMPLUS-15, LMPLUS-17 Patient Monitor Model PM-2000M MM17 PM-2000M 15 Patient Monitor elite V5, elite V6, elite V8 Pulse Oximeter model PO-100B H100B Pulse Oximeter Handheld pulsed oximeter model EHP2 Handheld pulse oximeter model EHP2-HRP7 Pulse Oximeter model LX-100 Handheld pulse oximeter model EHP2-HRP6 SD3 Series Ultrasonic Pocket Doppler: SD3 LITE, SD3, SD3 PLUS, SD3 PRO, SD3 VASCULAR Electrocardiograph model SL6A,CardioExpress SL6 SE-601 series Electrocardiograph Electrocardiograph models ECG-6,ECG-6 Plus,ECG-6 Pro Vital Signs Monitor, models: iM3s, iM3As, iM3Bs, iHM3s Electrocardiograph, Model SL18A Electrocardiograph, Model SE-18 Acclarix AX8 Exp, Acclarix AX8 Super, Acclarix AX9 Basic, Acclarix AX9, Acclarix AX9 Exp, Acclarix AX9 Super, Acclarix AX85, Acclarix AX88. Acclarix AX7, Acclarix AX8, Acclarix AX75, Acclarix AX78, Diagnostic Ultrasound System, Models: Acclarix AX18, Diagnostic Ultrasound System, Models: Acclarix LX3, Acclarix LX3 Exp, Acclarix LX3 Super, Acclarix LX25, Acclarix LX28 Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3 Super, Acclarix AX25, Acclarix AX28, Diagnostic Ultrasound System, Models: Acclarix AX2, Acclarix AX2 Exp, Acclarix AX2 Super, Acclarix AX15, Electrocardiograph models SE-12,SE-1200,SE-12 Express,SE-1200 Express Electrocardiograph models: ECG-12 Plus; ECG-12 Plus/ST; ECG-12; ECG-12 B; ECG-12 C; ECG-1200; ECG-1200 Plus Electrocardiograph models: CardioExpress SL12, SL12A,RECORDING PAPER Z-FOLD Electrocardiograph models: LE-12CH Electrocardiograph Model: SE-1200 Pro,SE-1201 Pro Patient Monitor models M50 and M80 Stimulation System: PA4 Pro; PA4; PA36; PA38; PR4 Pro; PR4; PR36; PR38; Q3; Q9; Q10; Q12; S6; S9; S10; S12; RespArray L-USG-P UMS 600 DUS-6000 P3 Digital Ultrasonic Diagnostic Imaging System DUS60 Patient Monitor, model iM20 PM-2000TM Acclarix AX4 Diagnostic Ultrasound System Fetal & maternal monitor models FM-9000, FM-9000Plus Fetal & maternal monitor, models F6, F9, F6 Express & F9 Express Fetal & maternal monitor, model: F15A, F15A Air Central Monitoring System model CMS-1000FM Central Monitoring System model MFM-CNS; MFM-CNS Lite Ambulatory Blood Pressure Monitor Model : SA-05, SA-06, SA-08, SA-09, SA-10 Diagnostic Ultrasound Systems, model U2 P10 DUS-5000 Diagnostic Ultrasound System, model:U50 Ultrasonic TableTop Doppler Models TD-5000,TD-6000 SD5 & SD6 Ultrasonic Tabletop Doppler iM60, iM70 Patient monitor Patient monitor LM-10, LM-12 Patient monitor:Waveline EZ MAX Patient monitor iM60A PM-2000XL Plus Tecme Central Monitoring System MFM-CMS MFM-CMS Central Monitoring System Electrocardiograph models SE-3,SE-300A,SE-300B Electrocardiograph models SE-301 Electrocardiograph model CardioExpress SL3 Patient Monitor, models:iX10, iX12, iX15 Tecme Patient Monitor iX10; Tecme Patient Monitor iX12; Tecme Patient Monitor iX15; DRE WAVELINE SV10; DRE WAVELINE SV12; DRE WAVELINE SV15 Diagnostic Ultrasound System, models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3 Super, Acclarix AX25, Acclarix AX28, Acclarix AX2, Acclarix AX2 Exp, Acclarix AX2 Super, Acclarix AX15, Acclarix AX18 Fetal Monitor Model F2 and F3 Fetal monitor models FM-3000 Digital Ultrasonic Diagnostic Imaging System models DUS3, DUS 6 Digital Ultrasonic Diagnostic Imaging System models DUS-3000,DUS-3000Plus Holter System, model LH-12 Holter System, models SE-2003 and SE-2012 Telemetry Transmitter iT20 PC ECG, model PADECG Patient Monitor, models: CX10, CX12, CX15, UX10, UX12, UX15 Patient Monitor: X8,X10,X12 Patient Monitor:X8s, X10s,X12s Patient Monitor models iM50,iM80 Patient Monitor models LM-8, LM-15 Patient Monitor models PM-2000XL,PM-2000XL Pro i15A Blood Gas and Chemistry Analysis System i15 Blood Gas and Chemistry Analysis System i15A Hematocrit Control,i15A Blood Gas and Electrolyte Control,i15A Calibrant Fluid Pack i15 Calibrant Fluid Pack,i15 Blood Gas and Electrolyte Control, i15 Hematocrit Control Diagnostic Ultrasound System, Model: Nano C5 EXP, Nano L12 EXP, Nano C5, Nano L12 Fetal Monitor, Model:F2,F3 Fetal Monitor, Models FM-3000 Fetal Monitor, model LC-TWIN Electrocardiograph Model: iSE-1210,iSE-1810 Vital Signs Monitor model VSM-300B M3B Vital Signs Monitor Ultrasonic Pocket Doppler,Model: SD1 Diagnostic Ultrasound Systems, model U60 Ultrasonic Pocket Doppler, models LFD-PRO, LFD-PLUS Ultrasonic pocket doppler models Sonotrax vascular, Sonotrax Lite, Sonotrax BASIC Ultrasonic Pocket Doppler, models Sonotrax pro, SonoTrax BASIC A, SonoTrax II, SonoTrax II Pro Ultrasonic pocket doppler models PD-100A,PD-100Plus, PD-100Pro,PD-1000,PD-1000Plus,PD-1000Pro,PD-100B Patient monitor model: iM60A Patient Monitor models PM-2000XL,PM-2000XL Pro, PM-2000XL Plus Patient Monitor models M50, M80, iM50, iM80, iM60, iM70 Patient Monitor models LM-10, LM-12,LM-8, LM-15 Patient monitor model:Waveline EZ MAX PC ECG, model LE-1515 (LSTR-12-receiver, LSTR-12-transmitter) PC ECG, model SE-1515 (DX12-receiver, DX12-transmitter) Electrocardiograph Model ECG-1201 Electrocardiograph model SE-1201

Establishment Types

Manufacture Medical Device