BEUDAMED
    FDA Registration Active 🇨🇳 China

    ORANTECH INC.

    Reg #: 3013783488 · FEI: 3013783488 · Expires 2026
    View on FDA
    Products
    39
    Proprietary Names
    29
    Establishment Types
    3
    Classifications
    39

    Registration Details

    Registration Name
    ORANTECH INC.
    Registration Number
    3013783488
    FEI Number
    3013783488
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Zone#A,4F,1st Bld,7th Industrial Zone,Yulv Community, GongMing, Guangming New District,
    City
    Shenzhen Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K203620

    Owner / Operator

    Firm Name
    Orantech Inc.
    Operator Number
    10058634
    Address
    Zone#A,4F,1st Bld,7th Industrial Zone,Yulv Community, GongMing, Guangming New District,
    City
    Shenzhen
    State
    Guangdong
    Postal Code
    518106
    Country
    CN
    Correspondent
    Yuanlan Zeng

    US Agent

    Business Name
    Medten USA Inc.
    Contact Name
    Andres Orjuela
    Address
    1 Technology Dr. Suite B115 Irvine, CA 92618
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US
    Email
    [email protected]
    Phone
    925 3599115

    Products

    Device Name Product Code
    Tape And Bandage, Adhesive KGX
    Drain, Tee (Water Trap) BYH
    Airway, Oropharyngeal, Anesthesiology CAE
    Cable, Electrode IKD
    Bandage, Elastic FQM
    Blood Pressure Cuff DXQ
    Stethoscope, Manual LDE
    System, Monitoring, Perinatal HGM
    Circuit, Breathing (W Connector, Adaptor, Y Piece) CAI
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Oximeter DQA
    Analyzer, Gas, Oxygen, Gaseous-Phase CCL
    Continuous Measurement Thermometer FLL
    Cannula, Nasal, Oxygen CAT
    Tourniquet, Pneumatic KCY
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
    Monitor, Uterine Contraction, External (For Use In Clinic) HFM
    Transducer, Pressure, Intrauterine HFN
    Transducer, Ultrasonic, Obstetric HGL
    Alarm, Blood-Pressure DSJ
    Plethysmograph, Photoelectric, Pneumatic Or Hydraulic JOM
    Computer, Blood-Pressure DSK
    Computer, Diagnostic, Pre-Programmed, Single-Function DXG
    Detector And Alarm, Arrhythmia DSI
    Amplifier And Signal Conditioner, Transducer Signal DRQ
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Recorder, Paper Chart DSF
    System, Network And Communication, Physiological Monitors MSX
    Cable, Transducer And Electrode, Patient, (Including Connector) DSA
    Transducer, Blood-Pressure, Extravascular DRS
    Transmitters And Receivers, Physiological Signal, Radiofrequency DRG
    System, Pressure Measurement, Intermittent JFC
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Tubing, Pressure And Accessories BYX
    Infusor, Pressure, For I.V. Bags KZD
    Electrode, Electrocardiograph DRX
    Clinical Electronic Thermometer SDV
    Device, Medical Examination, Ac Powered KZF
    Orthosis, Limb Brace IQI

    Proprietary Names

    Accessories-Purpose Spo2 sensors securement device; Orantech Y sensor, Nellcor D-YS sensor and Masimo Multi-site sensor Water trap; Water trap set Oral-pharyngeal Airway Flexi 2G SAD Introducer; Guedel Airway; Laryngeal Mask; Laryngeal Mask introducer; Laryngeal Mask W/Gastirc Access; Leg plate adaptors ECG Trunk cables and leadwires, Trunk Cables(IBP cables, Spo2 cables, Temp. Cables), Adapter cables, Adaptors, Bandage, Elastic manometer, cuff, cuff bladder, inflation bulb and optioned Blood pressure cuffs (Adult/Pediatric/Infant/Neonate) Tenacore fetal ultrasound and toco transducers Breathing circuit adaptor BAG TUBE, ADULT, REUSABLE, HYTREL, 1.5m Carbon Dioxide monitoring CTM EtCo2 sensor Aneroid Sphygmomanometer Reusable Spo2 sensors and Disposable Spo2 sensors IT Dr.Gamber medical oxygen sensors OS and M series TS series skin and general/oral temperature probes Accessories of Tourniquet, Pneumatic -Reusable tourniquet Cuffs, Disposable tourniquet Cuffs, air hoses, connectors Non Invasive Blood Pressure Measurement Hose; Reusable NIBP Hose; Connection tube Electrosurgical Pads ECG/EKG trunk cables and lead wires, Disposable ECG lead wires Pressure Hose Assemblies Disposable Electrosurgical Active Electrodes (Electrosurgical Pencils) Pressure infusion bag, reusable and disposable 500ml/1000ml/3000ml Chest suction electrodes, Limb clamps electrodes, Disposable ECG monitoring electrodes, Prewired neonate ECG electrodes Zhejiang Haisheng compatible DBPT series disposable blood pressure transducer Probe Covers; Disposable Ear Thermometer Probe Cover Examination Lights Calf thigh DVT; dvt sleeve

    Establishment Types

    Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device for Another Party (Contract Manufacturer)