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Data / Medical devices / China / Wenzhou Caretek Medical Device Co., Ltd

Wenzhou Caretek Medical Device Co., Ltd: FDA-registered device maker in Wenzhou Zhejiang, China, 15 510(k) clearances

Wenzhou Caretek Medical Device Co., Ltd is registered with the FDA (registration 3007703436) in Wenzhou Zhejiang, China. It lists 30 device types. The FDA files 15 510(k) clearances under its listings, the newest dated April 3, 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.

Get makers like this oneWatch Wenzhou Caretek Medical Device Co., Ltd
FDA registration number
3007703436
Address
Room 1301.Yue Shang Mansion.Nanhui.Lucheng., Wenzhou Zhejiang, China, 325000
Owner or operator
Wenzhou Caretek Medical Device Co., Ltd (10029464)
Roles
Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer
First device listed
May 18, 2009
Registered through
2026
Brand names listed
Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscope, BLOOD PRESSURE CUFF 2, BLOOD PRESSURE CUFF 3, Baby Scale, Bite Block-adult-Velcro strap for Endoscopic, Bite Block-adult-latex free strap for Endoscopic, Bite Block-adult-no strap for Endoscopic and more

Devices it lists

DeviceProduct codeClassRoleSource
Blade, ScalpelGES1Exporter to the USaccessdata.fda.gov
Blood Pressure CuffDXQ2Contract manufacturer, Exporter to the USaccessdata.fda.gov
Bottle, Hot/Cold WaterFPF1Exporter to the USaccessdata.fda.gov
Clinical Electronic ThermometerSDV2Exporter to the USaccessdata.fda.gov
Container, SharpsMMK2Exporter to the USaccessdata.fda.gov
Container, Specimen, Non-SterileNNI1Exporter to the US, Manufactureraccessdata.fda.gov
Continuous Measurement ThermometerFLL2Exporter to the US, Foreign private label distributoraccessdata.fda.gov
Endoscopic Bite BlockMNK1Manufactureraccessdata.fda.gov
EsthesiometerGXB1Exporter to the US, Manufactureraccessdata.fda.gov
Goniometer, NonpoweredKQW1Exporter to the US, Manufactureraccessdata.fda.gov
Hammer, SurgicalFZY1Manufactureraccessdata.fda.gov
Infusor, Pressure, For I.V. BagsKZD1Exporter to the USaccessdata.fda.gov
Irrigator, SinusKAR1Exporter to the US, Manufactureraccessdata.fda.gov
Kit, First Aid, TalkingOVR1Contract manufactureraccessdata.fda.gov
Light, Examination, Medical, Battery PoweredKYT1Exporter to the US, Manufactureraccessdata.fda.gov
Marker, SkinFZZ1Manufactureraccessdata.fda.gov
Mask, OxygenBYG1Manufactureraccessdata.fda.gov
Mask, ScavengingKHA1Exporter to the USaccessdata.fda.gov
Non-Surgical GownOEA1Exporter to the USaccessdata.fda.gov
OtoscopeERA1Exporter to the US, Manufactureraccessdata.fda.gov
PercussorGWZ1Exporter to the US, Manufactureraccessdata.fda.gov
Retractor, All TypesEIG1Exporter to the US, Manufactureraccessdata.fda.gov
Scale, PatientFRW1Manufactureraccessdata.fda.gov
Scissors, Medical, DisposableJOK1Exporter to the US, Manufactureraccessdata.fda.gov
Stethoscope, ManualLDE1Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Syringe, EntKCP1Manufactureraccessdata.fda.gov
System, Measurement, Blood-Pressure, Non-InvasiveDXN2Exporter to the USaccessdata.fda.gov
System, Pressure Measurement, IntermittentJFC1Manufactureraccessdata.fda.gov
Tape, Measuring, Rulers And CalipersFTY1Manufactureraccessdata.fda.gov
Tourniquet, NonpneumaticGAX1Manufactureraccessdata.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 3, 2024K230889Digital ThermometerFLLSubstantially EquivalentWenzhou Yosun Medical Technology Co.,Ltdaccessdata.fda.gov
December 15, 2023K231478Digital Blood Pressure Monitor (Model: YB-800)DXNSubstantially EquivalentWenzhou Yosun Medical Technology Co.,Ltdaccessdata.fda.gov
June 28, 2023K230859Aneroid SphygmomanometerDXQSubstantially EquivalentWenzhou Kangshun Medical Devices Co.,Ltdaccessdata.fda.gov
October 23, 2020K201843Infrared ear and forehead thermometer, model YI-100FLLSubstantially EquivalentWenzhou Yosun Medical Technology Co.,Ltdaccessdata.fda.gov
January 3, 2019K180984Maxcon Sharps ContainerMMKSubstantially EquivalentNingbo Maxcon Medical Technology Co., Ltd.accessdata.fda.gov
November 28, 2018K180207Non-contact Infrared ThermometerFLLSubstantially EquivalentAlicn Medical (Shenzhen), Inc.accessdata.fda.gov
November 20, 2018K182652COCET Digital Thermometer (Models KFT-01/KFT-02/KFT-03/KFT-04/KFT-05/KFT-06/KFT-07/KFT-08/KFT-09/KFT-10FLLSubstantially EquivalentKangfu Medical Equipment Factoryaccessdata.fda.gov
August 1, 2016K160999Infra-red forehead thermometerFLLSubstantially EquivalentHangzhou Hua'An Medical&Health Instruments Co.,Ltdaccessdata.fda.gov
December 13, 2010K102718DIGITAL THERMOMETER; DIGITAL THERMOMETERFLLSubstantially EquivalentInternational Regulatory Consultants, LLC (Irc)accessdata.fda.gov
April 9, 2009K090014CAREMATE SPHYGMOMANOMETER WITH STETHOSCOPEDXQSubstantially EquivalentCaremate Medical Device Co., Ltd.accessdata.fda.gov
October 27, 2008K083043KING`YIELD WRIST BLOOD PRESSURE MONITOR, MODEL BP201DXNSubstantially EquivalentShenzhen Kingyield Technology Co., Ltd.accessdata.fda.gov
September 3, 2008K082042GONGDONG DISPOSABLE SHARP CONTAINERMMKSubstantially EquivalentZhejiang Gongdong Medical Plastic Factoryaccessdata.fda.gov
September 13, 2004K041694DIGITAL FLEXIBLE THERMOMETER, BASIC DIGITAL THERMOMETER, DITITAL PACIFIER THERMOMETERFLLSubstantially EquivalentHangzhou Hua'An Medical & Health Instruments Co.,accessdata.fda.gov
October 31, 1995K951041BLOOD PRESSURE CUFF 3DXQSubstantially EquivalentPedia Pals, Inc.accessdata.fda.gov
October 31, 1995K951040BLOOD PRESSURE CUFF 2DXQSubstantially EquivalentPedia Pals, Inc.accessdata.fda.gov

Compare with other makers

Updated April 3, 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.