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Data / Medical devices / China / Xiamen Firstcare Imp. & Exp. Co.,ltd.

Xiamen Firstcare Imp. & Exp. Co.,ltd.: FDA-registered device maker in Xiamen Fujian, China, 13 510(k) clearances

Xiamen Firstcare Imp. & Exp. Co.,ltd. is registered with the FDA (registration 3015422337) in Xiamen Fujian, China. It lists 40 device types. The FDA files 13 510(k) clearances under its listings, the newest dated April 4, 2024. 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
3015422337
Address
602-1, Bldg. 2A, Torch Xinke Plaza, No.2 Weili Road, Xiamen Fujian, China, 361015
Owner or operator
Xiamen FirstCare Imp. & Exp. Co.,ltd. (10062096)
Roles
Exporter to the US
First device listed
December 17, 2019
Registered through
2026
Brand names listed
AIRWAY, NASOPHARYNGEAL, Adhesive Bandages, Adjustable Cervical Collar, Airway, Alcohol prep pad, Alcohol swab sticks, Aluminum Crutches, Aluminum Penlight and more

Devices it lists

DeviceProduct codeClassRoleSource
Airway, NasopharyngealBTQ1Exporter to the USaccessdata.fda.gov
Airway, Oropharyngeal, AnesthesiologyCAE1Exporter to the USaccessdata.fda.gov
Bandage, ElasticFQM1Exporter to the USaccessdata.fda.gov
Bedding, Disposable, MedicalKME1Exporter to the USaccessdata.fda.gov
Blood Pressure CuffDXQ2Exporter to the USaccessdata.fda.gov
Clinical Electronic ThermometerSDV2Exporter to the USaccessdata.fda.gov
Clip, Removable (Skin)FZQ1Exporter to the USaccessdata.fda.gov
Continuous Measurement ThermometerFLL2Exporter to the USaccessdata.fda.gov
CrutchIPR1Exporter to the USaccessdata.fda.gov
Depressor, Tongue, Non-SurgicalFMA1Exporter to the USaccessdata.fda.gov
Device, Pressure ApplyingKNM1Exporter to the USaccessdata.fda.gov
Disinfectant, Medical DevicesLRJ1Exporter to the USaccessdata.fda.gov
Dressing, CompressionMHW1Exporter to the USaccessdata.fda.gov
Dressing, Wound, DrugFROUExporter to the USaccessdata.fda.gov
Dressing, Wound, Hydrogel Without Drug And/Or BiologicNAE1Exporter to the USaccessdata.fda.gov
Dressing, Wound, OcclusiveNAD1Exporter to the USaccessdata.fda.gov
Fentanyl And Other Opioid Protection GloveQDO1Exporter 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
Hemostatic Wound Dressing Without Thrombin Or Other BiologicsQSYUExporter to the USaccessdata.fda.gov
Light, Examination, Medical, Battery PoweredKYT1Exporter to the USaccessdata.fda.gov
Lubricant, PatientKMJ1Exporter to the USaccessdata.fda.gov
Mask, OxygenBYG1Exporter to the USaccessdata.fda.gov
Medical Glove, SpecialtyLZC1Exporter to the USaccessdata.fda.gov
Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy DrugsOPJ1Exporter to the USaccessdata.fda.gov
Mouthpiece, BreathingBYP1Exporter to the USaccessdata.fda.gov
Non-Surgical GownOEA1Exporter to the USaccessdata.fda.gov
Orthosis, CervicalIQK1Exporter to the USaccessdata.fda.gov
OximeterDQA2Exporter to the USaccessdata.fda.gov
Pack, Hot Or Cold, DisposableIMD1Exporter to the USaccessdata.fda.gov
Polymer Patient Examination GloveLZA1Exporter to the USaccessdata.fda.gov
Scissors, Medical, DisposableJOK1Exporter to the USaccessdata.fda.gov
Skin Prep TrayOJU1Exporter to the USaccessdata.fda.gov
Sling, ArmILI1Exporter to the USaccessdata.fda.gov
Splint, Extremity, Non-Inflatable, External, Non-SterileNOC1Exporter to the USaccessdata.fda.gov
Splint, Hand, And ComponentsILH1Exporter to the USaccessdata.fda.gov
Stethoscope, ManualLDE1Exporter to the USaccessdata.fda.gov
Sunglasses (Non-Prescription Including Photosensitive)HQY1Exporter to the USaccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Exporter to the USaccessdata.fda.gov
Valve, Non-RebreathingCBP2Exporter 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
April 4, 2024K240361Powder Free Green Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Pink Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Purple Nitrile Examination Gloves (XS/S/M/L/XL)LZASubstantially EquivalentHebei Titans Hongsen Medical Technology Co., Ltd.accessdata.fda.gov
January 26, 2024K233598Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other DrugsLZASubstantially EquivalentAnhui Intco Medical Products Co., Ltd.accessdata.fda.gov
October 16, 2022K221979Pulse Oximeter (Model C101A2, C101B1, C101A3)DQASubstantially EquivalentShenzhen Imdk Medical Technology Co., Ltd.accessdata.fda.gov
February 10, 2022K211570Zeolite Hemostatic GauzeQSYSubstantially EquivalentHangzhou Zeo-Innov Life Technology Co., Ltd.accessdata.fda.gov
March 22, 2021K202009Probe Cover: JZ-KBT-001, JZ-KBT-002, JZ-KBT-005, JZ-KBT-007, JZ-KBT-008, JZ-KBT-009, JZ-KBT-010, JZ-KBT-015, JZ-KBT-025, JZ-KBT-026FLLSubstantially EquivalentShenzhen Juzhong Technology Co., Ltd.accessdata.fda.gov
May 22, 2019K190902RH non-Automated Blood Pressure Meter RH non-Automated Blood Pressure Meter with StethoscopeDXQSubstantially EquivalentWenzhou Renhua Instruments Co., Ltd.accessdata.fda.gov
November 17, 2017K171961Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm)CBPSubstantially EquivalentXiamen Compower Medical Tech. Co., Ltd.accessdata.fda.gov
June 18, 2015K150340POWDER FREE Nitrile GLOVES (White), POWDER FREE Nitrile GLOVES (Cobalt Blue), POWDER FREE Nitrile GLOVES (Black), POWDER FREE Nitrile GLOVES (Ice Blue)LZASubstantially EquivalentHebei Hongsen Plastics Technology Co, Ltd.accessdata.fda.gov
June 1, 2015K143335Roosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate Dressing with Preservative (OTC)FROSubstantially EquivalentRoosin Medical Devices Co., Ltd.accessdata.fda.gov
October 15, 2013K130231NON-CONTACT INFRARED THERMOMETERFLLSubstantially EquivalentJinxinbao Electronic Co.,Ltdaccessdata.fda.gov
September 25, 2013K131440POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUELZASubstantially EquivalentHebei Hongsen Plastics Technology Co, Ltd.accessdata.fda.gov
August 3, 2012K121526POWER-FREE NITRILE PATIENT EXAMINATION GLOVESLZASubstantially EquivalentShandong Junchi Medical Products Co., Ltd.accessdata.fda.gov
April 29, 1994K935037NON-PRESCRIPTION SUNGLASSESHQYSubstantially EquivalentXiamen Chenyi Plastics Industrial Co. , Ltd.accessdata.fda.gov

Compare with other makers

Updated April 4, 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.