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Data / Medical devices / China / Orantech Inc.

Orantech Inc.: FDA-registered device maker in Shenzhen Guangdong, China, 13 510(k) clearances

Orantech Inc. is registered with the FDA (registration 3013783488) in Shenzhen Guangdong, China. It lists 39 device types. The FDA files 13 510(k) clearances under its listings, the newest dated January 8, 2024. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Orantech Inc.
FDA registration number
3013783488
Address
Zone#A,4F,1st Bld,7th Industrial Zone,Yulv Community, GongMing, Guangming New District, Shenzhen Guangdong, China, 518106
Owner or operator
Orantech Inc. (10058634)
Roles
Contract manufacturer, Exporter to the US, Manufacturer
First device listed
October 17, 2018
Registered through
2026
Brand names listed
Accessories of Tourniquet, Pneumatic -Reusable tourniquet Cuffs, Disposable tourniquet Cuffs, air hoses, connectors, Aneroid Sphygmomanometer, BAG TUBE, ADULT, REUSABLE, HYTREL, 1.5m, Bandage, Elastic, Blood pressure cuffs (Adult/Pediatric/Infant/Neonate), Breathing circuit adaptor, Calf thigh DVT; dvt sleeve, Carbon Dioxide monitoring CTM EtCo2 sensor and more

Devices it lists

DeviceProduct codeClassRoleSource
Airway, Oropharyngeal, AnesthesiologyCAE1Exporter to the USaccessdata.fda.gov
Alarm, Blood-PressureDSJ2Exporter to the USaccessdata.fda.gov
Amplifier And Signal Conditioner, Transducer SignalDRQ2Exporter to the USaccessdata.fda.gov
Analyzer, Gas, Carbon-Dioxide, Gaseous-PhaseCCK2Manufactureraccessdata.fda.gov
Analyzer, Gas, Oxygen, Gaseous-PhaseCCL2Exporter to the USaccessdata.fda.gov
Bandage, ElasticFQM1Manufactureraccessdata.fda.gov
Blood Pressure CuffDXQ2Exporter to the US, Manufactureraccessdata.fda.gov
Cable, ElectrodeIKD2Manufactureraccessdata.fda.gov
Cable, Transducer And Electrode, Patient, (Including Connector)DSA2Exporter to the US, Manufactureraccessdata.fda.gov
Cannula, Nasal, OxygenCAT1Exporter to the US, Manufactureraccessdata.fda.gov
Circuit, Breathing (W Connector, Adaptor, Y Piece)CAI1Exporter to the US, Manufactureraccessdata.fda.gov
Clinical Electronic ThermometerSDV2Manufactureraccessdata.fda.gov
Computer, Blood-PressureDSK2Exporter to the USaccessdata.fda.gov
Computer, Diagnostic, Pre-Programmed, Single-FunctionDXG2Exporter to the USaccessdata.fda.gov
Continuous Measurement ThermometerFLL2Exporter to the US, Manufactureraccessdata.fda.gov
Detector And Alarm, ArrhythmiaDSI2Exporter to the USaccessdata.fda.gov
Device, Medical Examination, Ac PoweredKZF1Exporter to the USaccessdata.fda.gov
Drain, Tee (Water Trap)BYH1Exporter to the US, Manufactureraccessdata.fda.gov
Electrode, ElectrocardiographDRX2Exporter to the US, Manufactureraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Exporter to the USaccessdata.fda.gov
Infusor, Pressure, For I.V. BagsKZD1Exporter to the USaccessdata.fda.gov
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)DRT2Exporter to the USaccessdata.fda.gov
Monitor, Uterine Contraction, External (For Use In Clinic)HFM2Exporter to the USaccessdata.fda.gov
Orthosis, Limb BraceIQI1Exporter to the USaccessdata.fda.gov
OximeterDQA2Exporter to the US, Manufactureraccessdata.fda.gov
Plethysmograph, Photoelectric, Pneumatic Or HydraulicJOM2Exporter to the USaccessdata.fda.gov
Recorder, Paper ChartDSF1Exporter to the USaccessdata.fda.gov
Staple, Removable (Skin)GDT1Exporter to the USaccessdata.fda.gov
Stethoscope, ManualLDE1Exporter to the USaccessdata.fda.gov
System, Measurement, Blood-Pressure, Non-InvasiveDXN2Exporter to the USaccessdata.fda.gov
System, Monitoring, PerinatalHGM2Contract manufacturer, Exporter to the USaccessdata.fda.gov
System, Network And Communication, Physiological MonitorsMSX2Exporter to the USaccessdata.fda.gov
System, Pressure Measurement, IntermittentJFC1Manufactureraccessdata.fda.gov
Tourniquet, PneumaticKCY1Exporter to the USaccessdata.fda.gov
Transducer, Blood-Pressure, ExtravascularDRS2Exporter to the USaccessdata.fda.gov
Transducer, Pressure, IntrauterineHFN2Exporter to the USaccessdata.fda.gov
Transducer, Ultrasonic, ObstetricHGL2Exporter to the USaccessdata.fda.gov
Transmitters And Receivers, Physiological Signal, RadiofrequencyDRG2Exporter to the USaccessdata.fda.gov
Tubing, Pressure And AccessoriesBYX1Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
January 8, 2024K233615Electrosurgical Pads (GBS-Dm 1030ac, GBS-Db 1031ac, GBS-Dm 1030a, GBS-Db 1031a, GBS-Dm 1130ac, GBS-Db 1131ac, GBS-Dm 1130a, GBS-Db 1131a, GBS-Dm 1040ac, GBS-Db 1041ac, GBS-Dm 1040a, GBS-Db 1041a, GBS-Dm 1140ac, GBS-Db 1141ac, GBS-Dm 1140a, GBS-Db 1141a, GBS-Db 4030c, GBS-Db 4030, GBS-Db 4040c, GBS-Db 4040, GBS-Dm 1030bc, GBS-Db 1031bc, GBS-Dm 1030b, GBS-Db 1031b, GBS-Dm 1130bc, GBS-Db 1131bc, GBS-Dm 1130b, GBS-Db 1131b, GBS-Dm 1030nc, GBS-Db 1031nc, GBS-Dm 1030n, GBS-Db 1031n, GBS-Dm 1GEISubstantially EquivalentBaisheng Medical Co., Ltd.accessdata.fda.gov
March 23, 2021K203620Aneroid SphygmomanometerDXQSubstantially EquivalentWuxi Exanovo Medical Instrument Co., Ltd.accessdata.fda.gov
January 30, 2019K182327Patient Cables and Leadwires , Disposable ECG LeadwiresDSASubstantially EquivalentOrantech, Inc.accessdata.fda.gov
October 10, 2018K173194Temperature ProbeFLLSubstantially EquivalentOrantech, Inc.accessdata.fda.gov
September 7, 2018K181270Disposable SpO2 Sensors, Reusable SpO2 SensorsDQASubstantially EquivalentOrantech, Inc.accessdata.fda.gov
August 21, 2018K173197Reusable NIBP CuffDXQSubstantially EquivalentOrantech, Inc.accessdata.fda.gov
May 31, 2018K171828ETCO2 SensorCCKSubstantially EquivalentOrantech, Inc.accessdata.fda.gov
May 8, 2017K161938Fingertip Pulse OximeterDQASubstantially EquivalentXuzhou Yongkang Electronic Science Technology Co., Ltd.accessdata.fda.gov
October 31, 2016K152472Disposable Pressure TransducerDRSSubstantially EquivalentZhejiang Haisheng Medical Device Co., Ltd.accessdata.fda.gov
November 25, 2014K140535PHILIPS AVALON FETAL / MATERNAL MONITORS FM20, FM30, FM40 AND FM50HGMSubstantially EquivalentPhilips Medizin Systeme Boblingen GmbHaccessdata.fda.gov
August 15, 2008K081951ANEROID SPHYGMOMANOMETER, MODEL KT-A01DXQSubstantially EquivalentWenzhou Kindcare Import & Export Co., Ltd.accessdata.fda.gov
December 15, 2000K002384M-XX OXYGEN SENSORSCCLSubstantially EquivalentInternational Business Strategiesaccessdata.fda.gov
January 12, 1983K823670E.S. PENCILGEISubstantially EquivalentSurgicare Scientific Laboratory, Inc.accessdata.fda.gov

Compare with other makers

Updated January 8, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.