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Data / Medical devices / China / Emsrun Group

Emsrun Group: FDA-registered device maker in Wuxi Jiangsu, China, 1 510(k) clearance

Emsrun Group is registered with the FDA (registration 3012777736) in Wuxi Jiangsu, China. It lists 34 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 1, 2023. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Emsrun Group
FDA registration number
3012777736
Address
8-7 Huide Road, Huishan Area, Wuxi Jiangsu, China, 214000
Owner or operator
EMSRUN GROUP (10052960)
Roles
Exporter to the US, Manufacturer, Specification developer
First device listed
October 20, 2016
Registered through
2026
Brand names listed
Airway, Burn Dressing, Burn Gel, Carbon Fiber Scoop Stretcher, scoop stretcher, basket stretcher, multifunctional rescue stretcher, soft Stretcher,, Emergency Blanket, Evacuation Chair Stretcher, traction splint, FACE SHIELD, Goggle and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessory, Surgical ApparelLYU1Exporter to the USaccessdata.fda.gov
Adhesive Backed Thermal Skin PatchesOMW1Exporter to the USaccessdata.fda.gov
Airway, NasopharyngealBTQ1Manufactureraccessdata.fda.gov
Airway, Oropharyngeal, AnesthesiologyCAE1Exporter to the USaccessdata.fda.gov
Applicator, Absorbent Tipped, Non-SterileKXF1Exporter to the USaccessdata.fda.gov
Band Or Belt, Pelvic SupportISR1Specification developeraccessdata.fda.gov
Bandage, ElasticFQM1Manufactureraccessdata.fda.gov
Bed, ManualFNJ1Exporter to the USaccessdata.fda.gov
Bedding, Disposable, MedicalKME1Manufactureraccessdata.fda.gov
Dressing, Wound, Hydrogel Without Drug And/Or BiologicNAE1Exporter to the USaccessdata.fda.gov
Dressing, Wound, OcclusiveNAD1Manufactureraccessdata.fda.gov
First Aid Kit With DrugLRRNManufactureraccessdata.fda.gov
First Aid Kit Without DrugOHO1Manufactureraccessdata.fda.gov
ForcepsHTD1Exporter to the USaccessdata.fda.gov
Gauze / Sponge,Nonresorbable For External UseNAB1Manufactureraccessdata.fda.gov
Hemostatic Wound Dressing Without Thrombin Or Other BiologicsQSYUExporter to the USaccessdata.fda.gov
Light, Examination, Medical, Battery PoweredKYT1Exporter to the USaccessdata.fda.gov
Lubricant, PatientKMJ1Exporter to the USaccessdata.fda.gov
Mask, Oxygen, Non-RebreathingKGB1Manufactureraccessdata.fda.gov
Non-Surgical GownOEA1Exporter to the USaccessdata.fda.gov
Orthosis, CervicalIQK1Exporter to the USaccessdata.fda.gov
Orthosis, Truncal/Orthosis, LimbMRI1Exporter to the USaccessdata.fda.gov
Pack, Hot Or Cold, DisposableIMD1Specification developeraccessdata.fda.gov
Pad, EyeHMP1Exporter to the USaccessdata.fda.gov
Regulator, Pressure, Gas CylinderCAN1Exporter to the USaccessdata.fda.gov
Scissors, General, SurgicalLRW1Manufactureraccessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)HOY1Manufactureraccessdata.fda.gov
Splint, Extremity, Non-Inflatable, External, Non-SterileNOC1Specification developeraccessdata.fda.gov
Splint, Hand, And ComponentsILH1Specification developeraccessdata.fda.gov
Stethoscope, ManualLDE1Exporter to the USaccessdata.fda.gov
Stretcher, Hand-CarriedFPP1Specification developeraccessdata.fda.gov
Support, Patient PositionCCX1Exporter to the USaccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Specification developeraccessdata.fda.gov
Tourniquet, NonpneumaticGAX1Manufactureraccessdata.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
September 1, 2023K213413Hemostatic DressingQSYSubstantially EquivalentJiangsu Newvalue Medical Products Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated September 1, 2023. 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.