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
- [email protected]
- Phone
- 408 4211510
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2018-12-23 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2018-12-23 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2018-12-23 |
| Electrocardiograph, Ambulatory (Without Analysis) | MWJ | Class 2 | Cardiovascular | No | 2023-10-31 |
| Recorder, Magnetic Tape, Medical | DSH | Class 2 | Cardiovascular | No | 2023-10-31 |
| Colposcope (And Colpomicroscope), Exempt | PTZ | Class 2 | Obstetrics/Gynecology | No | 2017-07-17 |
| Cable, Transducer And Electrode, Patient, (Including Connector) | DSA | Class 2 | Cardiovascular | No | 2012-03-08 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | Class 2 | Cardiovascular | No | 2012-03-08 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | Class 2 | Cardiovascular | No | 2012-03-08 |
| Detector And Alarm, Arrhythmia | DSI | Class 2 | Cardiovascular | No | 2012-03-08 |
| Computer, Blood-Pressure | DSK | Class 2 | Cardiovascular | No | 2012-03-08 |
| Vectorcardiograph | DYC | Class 2 | Cardiovascular | No | 2021-10-17 |
| Electrocardiograph | DPS | Class 2 | Cardiovascular | No | 2021-10-17 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2019-03-29 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2019-03-29 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2019-03-29 |
| Treadmill, Powered | IOL | Class 1 | Physical Medicine | No | 2009-12-11 |
| Computer, Diagnostic, Programmable | DQK | Class 2 | Cardiovascular | No | 2026-02-10 |
| NSX | No | 2009-06-04 | |||
| Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | CBS | Class 2 | Anesthesiology | No | 2016-12-30 |
| Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) | NHQ | Class 2 | Anesthesiology | No | 2016-12-30 |
| Plethysmograph, Impedance | DSB | Class 2 | Cardiovascular | No | 2016-12-30 |
| Spirometer, Monitoring (W/Wo Alarm) | BZK | Class 2 | Anesthesiology | No | 2016-12-30 |
| Monitor, Breathing Frequency | BZQ | Class 2 | Anesthesiology | No | 2016-12-30 |
| Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | CBR | Class 2 | Anesthesiology | No | 2016-12-30 |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | Class 2 | Cardiovascular | No | 2016-12-30 |
| Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | CBQ | Class 2 | Anesthesiology | No | 2016-12-30 |
| Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) | NHO | Class 2 | Anesthesiology | No | 2016-12-30 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2016-12-30 |
| Analyzer, Gas, Oxygen, Gaseous-Phase | CCL | Class 2 | Anesthesiology | No | 2016-12-30 |
| Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) | NHP | Class 2 | Anesthesiology | No | 2016-12-30 |
| Monitor, St Segment With Alarm | MLD | Class 2 | Cardiovascular | No | 2016-12-30 |
| Monitor, Ultrasonic, Fetal | KNG | Class 2 | Obstetrics/Gynecology | No | 2015-03-30 |
| Flowmeter, Blood, Cardiovascular | DPW | Class 2 | Cardiovascular | No | 2015-03-30 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2021-01-28 |
| Recorder, Paper Chart | DSF | Class 1 | Cardiovascular | No | 2011-07-21 |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | Class 2 | Neurology | No | 2024-05-20 |
| Stimulator, Muscle, Powered | IPF | Class 2 | Physical Medicine | No | 2024-05-20 |
| System, Monitoring, Perinatal | HGM | Class 2 | Obstetrics/Gynecology | No | 2015-07-07 |
| Monitor, Uterine Contraction, External (For Use In Clinic) | HFM | Class 2 | Obstetrics/Gynecology | No | 2025-08-28 |
| Transducer, Ultrasonic, Obstetric | HGL | Class 2 | Obstetrics/Gynecology | No | 2025-08-28 |
| Alarm, Blood-Pressure | DSJ | Class 2 | Cardiovascular | No | 2025-08-28 |
| Transducer, Pressure, Intrauterine | HFN | Class 2 | Obstetrics/Gynecology | No | 2025-08-28 |
| System, Network And Communication, Physiological Monitors | MSX | Class 2 | Cardiovascular | No | 2024-02-06 |
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2017-02-13 |
| Electrode, Ion Specific, Calcium | JFP | Class 2 | Clinical Chemistry | No | 2016-07-25 |
| Calibrator, Multi-Analyte Mixture | JIX | Class 2 | Clinical Chemistry | No | 2016-07-25 |
| Electrode, Ion Specific, Sodium | JGS | Class 2 | Clinical Chemistry | No | 2016-07-25 |
| Instrument, Hematocrit, Automated | GKF | Class 2 | Hematology | No | 2016-07-25 |
| Controls For Blood-Gases, (Assayed And Unassayed) | JJS | Class 1 | Clinical Chemistry | No | 2016-07-25 |
| Electrode, Ion-Specific, Chloride | CGZ | Class 2 | Clinical Chemistry | No | 2016-07-25 |
| Control, Hematocrit | GLK | Class 2 | Hematology | No | 2016-07-25 |
| Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | CHL | Class 2 | Clinical Chemistry | No | 2016-07-25 |
| Electrode, Ion Specific, Potassium | CEM | Class 2 | Clinical Chemistry | No | 2016-07-25 |
| Monitor, Blood-Flow, Ultrasonic | HEP | Class 2 | Obstetrics/Gynecology | No | 2010-08-30 |
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