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Data / Medical devices / China / Shanghai Care Us Medical Product Co., Ltd.

Shanghai Care Us Medical Product Co., Ltd.: FDA-registered device maker in Shanghai, China, 1 510(k) clearance

Shanghai Care Us Medical Product Co., Ltd. is registered with the FDA (registration 3010700223) in Shanghai, China. It lists 30 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 9, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3010700223
Address
No.2, Lane 10, West Chenchuan Road Baoshan District, Shanghai, China, 200949
Owner or operator
Shanghai Care Us Medical Product Co., Ltd. (10046148)
Roles
Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler
First device listed
February 7, 2014
Registered through
2026
Brand names listed
ADJUSTABLE ELBOW SUPPORT, ADJUSTABLE KNEE SUPPORT, ADJUSTABLE, CONTOURED BACK SUPPORT, ADJUSTABLE, STABALIZING WRIST SUPPORT, Acne Patch, Athletic Tape, Burn kit without drug, CARE-US BLISTER CUSH ASTD 5CT ORIGINAL and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessory, Surgical ApparelLYU1Exporter to the US, Manufactureraccessdata.fda.gov
Adaptor, HygieneILS1Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Bag, Urine Collection, Leg, For External Use, SterileFAQ1Manufactureraccessdata.fda.gov
Bandage, ElasticFQM1Exporter to the US, Manufactureraccessdata.fda.gov
BedpanFOB1Exporter to the US, Manufactureraccessdata.fda.gov
Burn Kit Without DrugOJJ1Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Case, Contact LensLRX2Exporter to the US, Manufactureraccessdata.fda.gov
Container, Liquid Medication, GraduatedKYW1Manufactureraccessdata.fda.gov
Dilator, NasalLWF1Exporter to the US, Manufactureraccessdata.fda.gov
Disinfectant, Medical DevicesLRJ1Exporter to the US, Manufactureraccessdata.fda.gov
Dispenser, Liquid MedicationKYX1Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Dispenser, Solid MedicationNXB1Exporter to the US, Manufactureraccessdata.fda.gov
Dressing, Wound, Hydrogel Without Drug And/Or BiologicNAE1Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Dressing, Wound, HydrophilicNAC1Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Elastomer, Silicone, For Scar ManagementMDA1Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
First Aid Kit With DrugLRRNManufactureraccessdata.fda.gov
First Aid Kit Without DrugOHO1Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Gauze / Sponge,Nonresorbable For External UseNAB1Exporter to the US, Manufactureraccessdata.fda.gov
Insoles, MedicalKYS1Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Mask, OxygenBYG1Manufactureraccessdata.fda.gov
Mask, ScavengingKHA1Exporter to the US, Manufactureraccessdata.fda.gov
Orthosis, Limb BraceIQI1Manufactureraccessdata.fda.gov
Pack, Hot Or Cold, ReusableIME1Exporter to the US, Manufactureraccessdata.fda.gov
Pad, Heating, PoweredIRT2Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Pill Crusher/CutterOHY1Exporter to the US, Manufactureraccessdata.fda.gov
Protector, Skin PressureFMP1Exporter to the US, Manufactureraccessdata.fda.gov
Respirator, SurgicalMSH2Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Splint, Hand, And ComponentsILH1Exporter to the US, Manufactureraccessdata.fda.gov
Support, Patient PositionCCX1Exporter to the US, Manufactureraccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Contract manufacturer, Exporter 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
October 9, 2024K240095CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6)LRXSubstantially EquivalentShanghai Care US Medical Product Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated October 9, 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.