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Data / Medical devices / China / Suzhou Hengxiang Imp. & Exp. Co., Ltd

Suzhou Hengxiang Imp. & Exp. Co., Ltd: FDA-registered device maker in SUZHOU Jiangsu, China, 4 510(k) clearances

Suzhou Hengxiang Imp. & Exp. Co., Ltd is registered with the FDA (registration 9680934) in SUZHOU Jiangsu, China. It lists 35 device types. The FDA files 4 510(k) clearances under its listings, the newest dated June 16, 2009. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch Suzhou Hengxiang Imp. & Exp. Co., Ltd
FDA registration number
9680934
FEI number
3006993165
Address
18TH Fl.international Economy And Trade Building, 1638 Xihuan RD., SUZHOU Jiangsu, China, 215004
Owner or operator
SUZHOU HENGXIANG IMP. & EXP. CO., LTD (9010435)
Roles
Exporter to the US
First device listed
October 27, 2005
Registered through
2027
Brand names listed
Adult toothbrush,Kids toothbrush, Advantage Urinary Bags, Sterile, Allicator,absorbent tipped ,Sterile, Alpha Acupuncture Needles,, Apron, Adult Bibs, Protective Apron, Bandage, Cast, Cap, Disposable Nonwoven cap, Cotton Balls,Cotton Rolls,Cotton Strings,Cotton Pleats,Dental Cotton Rolls and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, Cleaning Brushes, For EndoscopeMNL1Exporter to the USaccessdata.fda.gov
Accessory, Surgical ApparelLYU1Exporter to the USaccessdata.fda.gov
Applicator, Absorbent Tipped, Non-SterileKXF1Exporter to the USaccessdata.fda.gov
Applicator, Absorbent Tipped, SterileKXG1Exporter to the USaccessdata.fda.gov
Apron, ProtectiveIWO1Exporter to the USaccessdata.fda.gov
Bag, Urine Collection, Leg, For External Use, Non-SterileNNW1Exporter to the USaccessdata.fda.gov
Bag, Urine Collection, Leg, For External Use, SterileFAQ1Exporter to the USaccessdata.fda.gov
Bandage, CastITG1Exporter to the USaccessdata.fda.gov
Bandage, ElasticFQM1Exporter to the USaccessdata.fda.gov
Bedding, Disposable, MedicalKME1Exporter to the USaccessdata.fda.gov
Brush, Scrub, Operating-RoomGEC1Exporter to the USaccessdata.fda.gov
Cap, SurgicalFYF1Exporter to the USaccessdata.fda.gov
Clamp, Surgical, General & Plastic SurgeryGDJ1Exporter to the USaccessdata.fda.gov
Collector, Urine, (And Accessories) For Indwelling CatheterKNX2Exporter to the USaccessdata.fda.gov
Cotton, RollEFN1Exporter to the USaccessdata.fda.gov
Cover, Shoe, Operating-RoomFXP1Exporter to the USaccessdata.fda.gov
Depressor, Tongue, Non-SurgicalFMA1Exporter to the USaccessdata.fda.gov
Drape, Surgical, AntimicrobialKKX2Exporter to the USaccessdata.fda.gov
Dress, SurgicalFYE1Exporter to the USaccessdata.fda.gov
Fiber, Medical, AbsorbentFRL1Exporter to the USaccessdata.fda.gov
First Aid Kit With DrugLRRNExporter to the USaccessdata.fda.gov
First Aid Kit Without DrugOHO1Exporter to the USaccessdata.fda.gov
Gauze / Sponge,Nonresorbable For External UseNAB1Exporter to the USaccessdata.fda.gov
Gown, ExaminationFME1Exporter to the USaccessdata.fda.gov
Lamp, Infrared, Therapeutic HeatingILY2Exporter to the USaccessdata.fda.gov
Marker, SkinFZZ1Exporter to the USaccessdata.fda.gov
Mask, ScavengingKHA1Exporter to the USaccessdata.fda.gov
Needle, Acupuncture, Single UseMQX2Exporter to the USaccessdata.fda.gov
Non-Surgical GownOEA1Exporter to the USaccessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)HOY1Exporter to the USaccessdata.fda.gov
Syringe, Irrigating (Non Dental)KYZ1Exporter to the USaccessdata.fda.gov
System, Urine Drainage, Closed, For Nonindwelling Catheter, SterileEYZ1Exporter to the USaccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Exporter to the USaccessdata.fda.gov
Toothbrush, ManualEFW1Exporter to the USaccessdata.fda.gov
Tubes, Gastrointestinal (And Accessories)KNT2Exporter to the USaccessdata.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
June 16, 2009K081720PRECISION TDP, HEAT AND INFRARED LAMPS AND MARVEL AND WONDER LAMPSILYSubstantially EquivalentPrime Herbs Corporationaccessdata.fda.gov
January 9, 2009K082863DYNAREX ENTERAL DELIVERY PUMP SET WITH SPIKE (1000ML), DYNAREX ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE (1000ML)KNTSubstantially EquivalentDynarex Corporationaccessdata.fda.gov
November 22, 2006K061517PRECISION PRESS TACK / INTRADERM, SEVEN STAR AND ACUPUNCTURE NEEDLES; ALPHA AND FINE POINT ACUPUNCTURE NEEDLESMQXSubstantially EquivalentPrime Herbs Corporationaccessdata.fda.gov
November 17, 2005K052169IMC SURGICAL DRAPESKKXSubstantially EquivalentInternational Medsurg Connection, Inc.accessdata.fda.gov

Compare with other makers

Updated June 16, 2009. 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.