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Data / Medical devices / China / Ningbo First Import & Export Co., Ltd.

Ningbo First Import & Export Co., Ltd.: FDA-registered device maker in NINGBO Zhejiang, China, 1 510(k) clearance

Ningbo First Import & Export Co., Ltd. is registered with the FDA (registration 3008427684) in NINGBO Zhejiang, China. It lists 37 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 20, 2017. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3008427684
Address
RM. 601, No. 500, Taikang Middle Road Yinzhou District, NINGBO Zhejiang, China, 315000
Owner or operator
NINGBO FIRST IMPORT AND EXPORT COMPANY LIMITED (10034975)
Roles
Exporter to the US, Manufacturer
First device listed
January 21, 2011
Registered through
2026
Brand names listed
APPLICATOR, Alcohol pre pad, BEDDING, Burn Dressing, COVER, MATTRESS (MEDICAL PURPOSES), COVER, SHOE, OPERATING-ROOM, CRUTCH, Cold Pack and more

Devices it lists

DeviceProduct codeClassRoleSource
Applicator, Absorbent Tipped, Non-SterileKXF1Exporter to the USaccessdata.fda.gov
Bandage, ElasticFQM1Exporter to the USaccessdata.fda.gov
Bedding, Disposable, MedicalKME1Exporter to the USaccessdata.fda.gov
Cover, Mattress (Medical Purposes)FMW1Exporter to the USaccessdata.fda.gov
Cover, Shoe, Operating-RoomFXP1Exporter to the USaccessdata.fda.gov
CrutchIPR1Exporter to the USaccessdata.fda.gov
Depressor, Tongue, Non-SurgicalFMA1Exporter to the USaccessdata.fda.gov
Disinfectant, Medical DevicesLRJ1Exporter to the USaccessdata.fda.gov
Dress, SurgicalFYE1Exporter to the USaccessdata.fda.gov
Dressing, CompressionMHW1Exporter to the US, Manufactureraccessdata.fda.gov
Dressing, Wound, Hydrogel Without Drug And/Or BiologicNAE1Exporter to the USaccessdata.fda.gov
Dressing, Wound, HydrophilicNAC1Exporter to the USaccessdata.fda.gov
Dressing, Wound, OcclusiveNAD1Exporter to the USaccessdata.fda.gov
First Aid Kit With DrugLRRNExporter to the USaccessdata.fda.gov
First Aid Kit Without DrugOHO1Exporter to the US, Manufactureraccessdata.fda.gov
Garment, Protective, For IncontinenceEYQ1Exporter to the US, Manufactureraccessdata.fda.gov
Gauze / Sponge,Nonresorbable For External UseNAB1Exporter to the USaccessdata.fda.gov
Gauze/Sponge, Internal, X-Ray DetectableGDY1Exporter to the USaccessdata.fda.gov
Gown, ExaminationFME1Exporter to the USaccessdata.fda.gov
Mask, ScavengingKHA1Exporter to the USaccessdata.fda.gov
Mouthpiece, BreathingBYP1Exporter to the US, Manufactureraccessdata.fda.gov
Non-Surgical GownOEA1Exporter to the USaccessdata.fda.gov
Pack, Hot Or Cold, DisposableIMD1Exporter to the USaccessdata.fda.gov
Pack, Hot Or Cold, ReusableIME1Exporter to the USaccessdata.fda.gov
Pad, Alcohol, Device DisinfectantLKBUExporter to the USaccessdata.fda.gov
Pad, EyeHMP1Exporter to the US, Manufactureraccessdata.fda.gov
Polymer Patient Examination GloveLZA1Exporter to the USaccessdata.fda.gov
Scissors, Medical, DisposableJOK1Exporter to the USaccessdata.fda.gov
Sheet, BurnFPY1Exporter to the USaccessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)HOY1Exporter to the USaccessdata.fda.gov
Shield, Protective, PersonnelKPY1Exporter to the USaccessdata.fda.gov
Sling, ArmILI1Exporter to the USaccessdata.fda.gov
Splint, Hand, And ComponentsILH1Exporter to the US, Manufactureraccessdata.fda.gov
Syringe, Irrigating (Non Dental)KYZ1Exporter to the USaccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Exporter to the USaccessdata.fda.gov
Toothbrush, ManualEFW1Exporter to the US, Manufactureraccessdata.fda.gov
Tourniquet, NonpneumaticGAX1Exporter to the US, Manufactureraccessdata.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
July 20, 2017K171616Xingyu Powder Free Nitrile Patient Examination Gloves, Blue colorLZASubstantially EquivalentShandong Xingyu Gloves Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated July 20, 2017. 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.