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Data / Medical devices / China / Jcmed Tianjin Import And Export Co., Ltd

Jcmed Tianjin Import And Export Co., Ltd: FDA-registered device maker in Tianjin, China, 4 510(k) clearances

Jcmed Tianjin Import And Export Co., Ltd is registered with the FDA (registration 3015821396) in Tianjin, China. It lists 51 device types. The FDA files 4 510(k) clearances under its listings, the newest dated May 5, 2022. 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.

FDA registration number
3015821396
Address
Room, Yuanhang Business Center, Lucia Commercial Street Airport Economic Zone, Tianjin, China, 300300
Owner or operator
JcMed TIANJIN Import and Export Co., Ltd (10081379)
Roles
Exporter to the US, Manufacturer
First device listed
April 8, 2021
Registered through
2026
Brand names listed
Adhesive Wound Dressing; Sterile Gauze Pad; ABD Pad; Non-Adherent Wound Pad; Gauze Roll; Gauze Swab;, Alcohol Prep Pad, Alginate dressing, Foam Dressing Set, Hydrophilic Dressing, Wound Plaster, Non Woven Dressing, Foam Dressing, Acne Patc, Alginate with Silver Dressing, Amorphous Hydrogel Dressing; Burn Dressing; Hydrogel Gauze; Hydrogel Medical Dressing, BZK Antiseptic Swab/Antiseptic Cleaning Wipes-Sting Free, Breathing Exerciser; Lung Trainer; One Ball Spirometer; Respiratory Excerciser; Respiratory Meter;Three Balls Spirometer, Cannula and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessory, Surgical ApparelLYU1Exporter to the USaccessdata.fda.gov
Airway, Oropharyngeal, AnesthesiologyCAE1Exporter to the USaccessdata.fda.gov
Bag, Urine Collecting, UreterostomyEXG1Exporter to the USaccessdata.fda.gov
Bag, Urine Collection, Leg, For External Use, Non-SterileNNW1Exporter to the US, Manufactureraccessdata.fda.gov
Balloon, EpistaxisEMX1Exporter to the US, Manufactureraccessdata.fda.gov
Bandage, ElasticFQM1Exporter to the US, Manufactureraccessdata.fda.gov
Bandage, Liquid, Skin ProtectantNEC1Exporter to the USaccessdata.fda.gov
Brush, Scrub, Operating-RoomGEC1Exporter to the USaccessdata.fda.gov
Cannula, InjectionFGY1Exporter to the USaccessdata.fda.gov
Cannula, Nasal, OxygenCAT1Exporter to the USaccessdata.fda.gov
Clip, Removable (Skin)FZQ1Exporter to the USaccessdata.fda.gov
Collector, Urine, (And Accessories) For Indwelling CatheterKNX2Exporter to the US, Manufactureraccessdata.fda.gov
Container, SharpsMMK2Exporter to the USaccessdata.fda.gov
Container, Specimen, SterileFMH1Exporter to the US, Manufactureraccessdata.fda.gov
Device, Fixation, Tracheal TubeCBH1Exporter to the USaccessdata.fda.gov
Device, Intravascular Catheter SecurementKMK1Exporter to the US, Manufactureraccessdata.fda.gov
Dilator, CatheterGCC1Exporter to the USaccessdata.fda.gov
Disinfectant, Medical DevicesLRJ1Exporter to the USaccessdata.fda.gov
Dressing, Wound, DrugFROUExporter to the US, Manufactureraccessdata.fda.gov
Dressing, Wound, Hydrogel Without Drug And/Or BiologicNAE1Exporter to the USaccessdata.fda.gov
Dressing, Wound, HydrophilicNAC1Exporter to the US, Manufactureraccessdata.fda.gov
Dressing, Wound, OcclusiveNAD1Exporter to the USaccessdata.fda.gov
Elastomer, Silicone, For Scar ManagementMDA1Exporter to the US, Manufactureraccessdata.fda.gov
Enema KitFCE1Exporter to the USaccessdata.fda.gov
Enzyme Immunoassay, PhencyclidineLCMUExporter to the USaccessdata.fda.gov
Exerciser, Non-MeasuringION1Exporter to the USaccessdata.fda.gov
First Aid Kit With DrugLRRNExporter to the US, Manufactureraccessdata.fda.gov
First Aid Kit Without DrugOHO1Exporter to the US, Manufactureraccessdata.fda.gov
Gauze / Sponge,Nonresorbable For External UseNAB1Exporter to the US, Manufactureraccessdata.fda.gov
Irrigator, Powered NasalKMA1Exporter to the USaccessdata.fda.gov
Mask, OxygenBYG1Exporter to the USaccessdata.fda.gov
Mask, Oxygen, Low Concentration, VenturiBYF1Exporter to the USaccessdata.fda.gov
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)CCQ1Exporter to the USaccessdata.fda.gov
Pack, Hot Or Cold, ReusableIME1Exporter to the USaccessdata.fda.gov
Pad, Alcohol, Device DisinfectantLKBUExporter to the USaccessdata.fda.gov
Protector, OstomyEXE1Exporter to the USaccessdata.fda.gov
Radiographic Protective GloveIWP1Exporter to the USaccessdata.fda.gov
Syringe, EntKCP1Exporter to the USaccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Exporter to the US, Manufactureraccessdata.fda.gov
Test, Amphetamine, Over The CounterNFT2Exporter to the USaccessdata.fda.gov
Test, Barbiturate, Over The CounterPTH2Exporter to the USaccessdata.fda.gov
Test, Benzodiazepine, Over The CounterNFV2Exporter to the USaccessdata.fda.gov
Test, Cannabinoid, Over The CounterNFW2Exporter to the USaccessdata.fda.gov
Test, Cocaine And Cocaine Metabolites, Over The CounterNFY2Exporter to the USaccessdata.fda.gov
Test, Methadone, Over The CounterPTG2Exporter to the USaccessdata.fda.gov
Test, Methamphetamine, Over The CounterNGG2Exporter to the USaccessdata.fda.gov
Test, Opiates, Over The CounterNGL2Exporter to the USaccessdata.fda.gov
Test, Propoxyphene, Over The CounterQBF2Exporter to the USaccessdata.fda.gov
Test, Tricyclic Antidepressants, Over The CounterQAW2Exporter to the USaccessdata.fda.gov
Tourniquet, NonpneumaticGAX1Exporter to the US, Manufactureraccessdata.fda.gov
Wound Dressing KitMCY2Exporter 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
May 5, 2022K220685HIGHTOP Multi-Drug Urine Test Cup, HIGHTOP Multi-Drug Urine Test Cup RxNFTSubstantially EquivalentQingdao Hightop Biotech Co., Ltd.accessdata.fda.gov
June 17, 2020K192478LT Antibacterial Alginate with Silver DressingFROSubstantially EquivalentZhejiang Longterm Medical Technology Co., Ltd.accessdata.fda.gov
April 22, 2014K140147BCT ANTIMICROBIAL DRESSING & BCT SILVER BANDAGEFROSubstantially EquivalentBio-Medical Carbon Technology Co., Ltd.accessdata.fda.gov
September 2, 2010K101567SHARPS CONTAINERMMKSubstantially EquivalentCixi Leinuo Plastic Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated May 5, 2022. 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.