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Data / Medical devices / China / Nanjing 3H Medical Products Co.,ltd.

Nanjing 3H Medical Products Co.,ltd.: FDA-registered device maker in NANJING Jiangsu, China, 1 510(k) clearance

Nanjing 3H Medical Products Co.,ltd. is registered with the FDA (registration 3007607706) in NANJING Jiangsu, China. It lists 25 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 24, 2021. 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.

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FDA registration number
3007607706
Address
No.1, No.5, Zhushan Road, Gaochun Economic Development Zone, NANJING Jiangsu, China, 211300
Owner or operator
NANJING 3H MEDICAL PRODUCTS CO.,LTD. (10027557)
Roles
Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler
First device listed
March 20, 2009
Registered through
2026
Brand names listed
Dressing, Compression, FIRST AID KIT WITHOUT DRUG, KIT, SURGICAL INSTRUMENT, DISPOSABLE, MYOTAPE nasal breathing tape, OKTAPE ADHESIVE TAPE, Pain Relief Patch, Stockings, Surgical mask (sterile) and more

Devices it lists

DeviceProduct codeClassRoleSource
Adhesive Backed Thermal Skin PatchesOMW1Manufactureraccessdata.fda.gov
Bag, IceKYR1Manufactureraccessdata.fda.gov
Bandage, ElasticFQM1Contract manufacturer, Manufactureraccessdata.fda.gov
Bath, Sitz, NonpoweredKTC1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Chair And Table, MedicalKMN1Repackager or relabeleraccessdata.fda.gov
Dispenser, Solid MedicationNXB1Repackager or relabeleraccessdata.fda.gov
Dressing, CompressionMHW1Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Dressing, Wound, Hydrogel Without Drug And/Or BiologicNAE1Manufactureraccessdata.fda.gov
Dressing, Wound, HydrophilicNAC1Contract manufacturer, Manufactureraccessdata.fda.gov
Dressing, Wound, OcclusiveNAD1Manufactureraccessdata.fda.gov
Elastomer, Silicone, For Scar ManagementMDA1Manufactureraccessdata.fda.gov
First Aid Kit Without DrugOHO1Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Joint, Ankle, External BraceITW1Contract manufacturer, Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Joint, Knee, External BraceITQ1Contract manufacturer, Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Kit, Surgical Instrument, DisposableKDD1Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Mask, SurgicalFXX2Manufactureraccessdata.fda.gov
Orthosis, Limb BraceIQI1Contract manufacturer, Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Pack, Hot Or Cold, DisposableIMD1Manufactureraccessdata.fda.gov
Scissors, General, SurgicalLRW1Contract manufacturer, Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Silicone Hydrogel For Scar ManagementPFP1Manufactureraccessdata.fda.gov
Stocking, ElasticILG1Exporter to the USaccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Contract manufacturer, Manufactureraccessdata.fda.gov
Tips And Pads, Cane, Crutch And WalkerINP1Repackager or relabeleraccessdata.fda.gov
UrinalFNP1Repackager or relabeleraccessdata.fda.gov
Utensil, EatingILC1Manufactureraccessdata.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
November 24, 2021K211295Surgical Mask (sterile)FXXSubstantially EquivalentNanjing 3h Medical Products Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated November 24, 2021. 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.