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Data / Medical devices / China / Hangzhou Primecare Medical Co.,Ltd.

Hangzhou Primecare Medical Co.,Ltd.: FDA-registered device maker in hangzhou Zhejiang, China, 7 510(k) clearances

Hangzhou Primecare Medical Co.,Ltd. is registered with the FDA (registration 3014637079) in hangzhou Zhejiang, China. It lists 29 device types. The FDA files 7 510(k) clearances under its listings, the newest dated April 17, 2024. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Hangzhou Primecare Medical Co.,Ltd.
FDA registration number
3014637079
Address
Room, Zancheng Center West, Shangcheng District, 310008 Hangzhou, PEOPLE'S REPUBLIC OF CHINA, hangzhou Zhejiang, China, 310008
Owner or operator
Hangzhou Primecare Medical Co.Ltd (10058286)
Roles
Contract manufacturer, Exporter to the US, Manufacturer
First device listed
August 15, 2018
Registered through
2026
Brand names listed
APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED, Catheter Care Tray, Foley insertion tray, Central Line Trays, Convenience Kits, Disposable Vaginal Speculum, Dressing change kit, ENEMA BUCKET 1500ML W/SOAP; ENEMA SET, Enteral Specific transition connector and more

Devices it lists

DeviceProduct codeClassRoleSource
Apparatus, Suction, Single Patient Use, Portable, NonpoweredGCY1Exporter to the US, Manufactureraccessdata.fda.gov
Bag, Urine Collection, Leg, For External Use, SterileFAQ1Exporter to the US, Manufactureraccessdata.fda.gov
Catheter And Tip, SuctionJOL2Exporter to the US, Manufactureraccessdata.fda.gov
Catheter Care TrayOHR2Exporter to the US, Manufactureraccessdata.fda.gov
Catheter, Retention Type, BalloonEZL2Exporter to the US, Manufactureraccessdata.fda.gov
Catheters, Suction, TracheobronchialBSY1Exporter to the US, Manufactureraccessdata.fda.gov
Collector, Urine, (And Accessories) For Indwelling CatheterKNX2Contract manufacturer, Exporter to the USaccessdata.fda.gov
Container, Specimen, Non-SterileNNI1Exporter to the US, Manufactureraccessdata.fda.gov
Container, Specimen, SterileFMH1Exporter to the US, Manufactureraccessdata.fda.gov
Device, Paste-On For Incontinence, Non-SterileNOA1Exporter to the US, Manufactureraccessdata.fda.gov
Device, Paste-On For Incontinence, SterileEXI1Exporter to the US, Manufactureraccessdata.fda.gov
Dispenser, Liquid MedicationKYX1Contract manufacturer, Exporter to the USaccessdata.fda.gov
Enema KitFCE1Exporter to the US, Manufactureraccessdata.fda.gov
Gastrointestinal Tubes With Enteral Specific ConnectorsPIF2Exporter to the US, Manufactureraccessdata.fda.gov
Intra-Abdominal Pressure Monitoring DevicePHUUExporter to the USaccessdata.fda.gov
Kit, Surgical Instrument, DisposableKDD1Exporter to the US, Manufactureraccessdata.fda.gov
Lubricant, PatientKMJ1Exporter to the US, Manufactureraccessdata.fda.gov
Medical Device Data SystemOUG1Exporter to the USaccessdata.fda.gov
Pump, Infusion, EnteralLZH2Exporter to the USaccessdata.fda.gov
Razor, SurgicalLWK1Exporter to the USaccessdata.fda.gov
Speculum, Vaginal, NonmetalHIB2Exporter to the USaccessdata.fda.gov
Suture Removal KitMCZ1Exporter to the US, Manufactureraccessdata.fda.gov
Syringe, Irrigating (Non Dental)KYZ1Exporter to the US, Manufactureraccessdata.fda.gov
Tracheostomy And Nasal Suctioning KitLRQ1Exporter to the US, Manufactureraccessdata.fda.gov
Tube, Aspirating, Flexible, ConnectingBYY2Exporter to the US, Manufactureraccessdata.fda.gov
Tubes, Gastrointestinal (And Accessories)KNT2Exporter to the US, Manufactureraccessdata.fda.gov
Urinary Drainage Collection Kit, For Indwelling CatheterFCN2Exporter to the US, Manufactureraccessdata.fda.gov
Urine Collection Kit (Excludes Hiv Testing)OIE1Exporter to the US, Manufactureraccessdata.fda.gov
UroflowmeterEXY2Exporter 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 17, 2024K240039Enteral Feeding SetsKNTSubstantially EquivalentHangzhou Primecare Medical Co., Ltd.accessdata.fda.gov
October 23, 2023K232205Vesco Q™ Enteral Feeding Pump; Vesco Q™ 500mL Bag Feed Set; Vesco Q™ 1000mL Bag Feed Set; Vesco Q™ 40mm Screw Cap Feed Set; Vesco Q™ ENPlus Feed SetLZHSubstantially EquivalentVesco Medical, LLCaccessdata.fda.gov
January 13, 2023K221020Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 FEZLUnknownPotrero Medical, Inc.accessdata.fda.gov
December 15, 2020K202698Prefilled SyringeEZLSubstantially EquivalentHangzhou Primecare Medical Co., Ltd.accessdata.fda.gov
August 3, 2020K192991Vesco Medical Extension Feeding SetPIFSubstantially EquivalentVesco Medical, LLCaccessdata.fda.gov
July 12, 2018K181276CONOD Enteral Feeding SetsPIFSubstantially EquivalentConod Medical Co., Limitedaccessdata.fda.gov
October 8, 2008K082815WELL LEAD SILICONE AND LATEX FOLEY CATHETERSEZLSubstantially EquivalentWell Lead Medical Instrumentsaccessdata.fda.gov

Compare with other makers

Updated April 17, 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.