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Data / Medical devices / Hong Kong / Yizur Ltd

Yizur Ltd: FDA-registered device maker in Hong Kong, Hong Kong, 19 510(k) clearances

Yizur Ltd is registered with the FDA (registration 3045855232) in Hong Kong, Hong Kong. It lists 84 device types. The FDA files 19 510(k) clearances under its listings, the newest dated August 27, 2025. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch Yizur Ltd
FDA registration number
3045855232
Address
Unit 2A, 17/F, Glenealy Tower, No.1 Glenealy, Hong Kong, Hong Kong, 999077
Owner or operator
Yizur Ltd (10095830)
Roles
Exporter to the US, Repackager or relabeler
First device listed
May 6, 2026
Registered through
2027
Brand names listed
Amalgam Carrier, Applicator, Applicator, Absorbent Tipped, Non-Sterile, BLADE, SCALPEL, Barrier Film, Bibs, CARVER, DENTAL AMALGAM, OPERATIVE, CUrette and more

Devices it lists

DeviceProduct codeClassRoleSource
Absorber, Saliva, PaperKHR1Exporter to the USaccessdata.fda.gov
Accessories, Retractor, DentalEIF1Exporter to the USaccessdata.fda.gov
Accessory, Surgical ApparelLYU1Exporter to the USaccessdata.fda.gov
Aligner, Bracket, OrthodonticECQ1Exporter to the USaccessdata.fda.gov
Alloy, Metal, BaseEJH2Exporter to the USaccessdata.fda.gov
Applicator, Absorbent Tipped, Non-SterileKXF1Exporter to the USaccessdata.fda.gov
Applicator, Absorbent Tipped, SterileKXG1Exporter to the USaccessdata.fda.gov
Applicator, ResinKXR1Exporter to the USaccessdata.fda.gov
Bedding, Disposable, MedicalKME1Exporter to the USaccessdata.fda.gov
Blade, ScalpelGES1Exporter to the USaccessdata.fda.gov
Bur, DentalEJL1Exporter to the USaccessdata.fda.gov
CaliperKTZ1Exporter to the USaccessdata.fda.gov
Carrier, Amalgam, OperativeEKI1Exporter to the USaccessdata.fda.gov
Carver, Dental Amalgam, OperativeEKH1Exporter to the USaccessdata.fda.gov
Cleanser, Denture, Over The CounterEFT1Exporter to the USaccessdata.fda.gov
Container, Liquid Medication, GraduatedKYW1Exporter to the USaccessdata.fda.gov
Cotton, RollEFN1Exporter to the USaccessdata.fda.gov
Cover, Mattress (Medical Purposes)FMW1Exporter to the USaccessdata.fda.gov
Cover, Shoe, Operating-RoomFXP1Exporter to the USaccessdata.fda.gov
Cup, ProphylaxisEHK1Exporter to the USaccessdata.fda.gov
CuretteHTF1Exporter to the USaccessdata.fda.gov
Dental Barriers And SleevesPEM2Exporter to the USaccessdata.fda.gov
Disk, AbrasiveEHJ1Exporter to the USaccessdata.fda.gov
Dispenser, Liquid MedicationKYX1Exporter to the USaccessdata.fda.gov
Elevator, Surgical, DentalEMJ1Exporter to the USaccessdata.fda.gov
Evacuator, Oral CavityEHZ1Exporter to the USaccessdata.fda.gov
Fentanyl And Other Opioid Protection GloveQDO1Exporter to the USaccessdata.fda.gov
File, Pulp Canal, EndodonticEKS1Exporter to the USaccessdata.fda.gov
Floss, DentalJES1Exporter to the USaccessdata.fda.gov
ForcepsHTD1Exporter to the USaccessdata.fda.gov
Forceps, Dressing, DentalEFL1Exporter to the USaccessdata.fda.gov
Gauze / Sponge,Nonresorbable For External UseNAB1Exporter to the USaccessdata.fda.gov
Gutta-PerchaEKM1Exporter to the USaccessdata.fda.gov
Handle, ScalpelGDZ1Exporter to the USaccessdata.fda.gov
Handpiece, Air-Powered, DentalEFB1Exporter to the USaccessdata.fda.gov
Hemostatic Wound Dressing Without Thrombin Or Other BiologicsQSYUExporter to the USaccessdata.fda.gov
Holder, Film, X-RayEGZ1Exporter to the USaccessdata.fda.gov
Indicator, Physical/Chemical Sterilization ProcessJOJ2Exporter to the USaccessdata.fda.gov
Instrument, Filling, Plastic, DentalEIY1Exporter to the USaccessdata.fda.gov
Instrument, Hand, Calculus RemovalELA1Exporter to the USaccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Exporter to the USaccessdata.fda.gov
Instruments, Dental HandDZN1Exporter to the USaccessdata.fda.gov
Knife, SurgicalEMF1Exporter to the USaccessdata.fda.gov
Mask, SurgicalFXX2Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Material, Impression Tray, ResinEBH1Exporter 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
Mirror, MouthEAX1Exporter to the USaccessdata.fda.gov
Mouthpiece, Saliva EjectorDYN1Exporter to the USaccessdata.fda.gov
Needle, DentalDZM1Exporter to the USaccessdata.fda.gov
Non-Surgical GownOEA1Exporter to the USaccessdata.fda.gov
Paper, ArticulationEFH1Exporter to the USaccessdata.fda.gov
Patient Personal Hygiene KitNSB1Exporter to the USaccessdata.fda.gov
Pliers, SurgicalHTC1Exporter to the USaccessdata.fda.gov
Plugger, Root Canal, EndodonticEKR1Exporter to the USaccessdata.fda.gov
Point, AbrasiveEHL1Exporter to the USaccessdata.fda.gov
Point, Paper, EndodonticEKN1Exporter to the USaccessdata.fda.gov
Polymer Patient Examination GloveLZA1Exporter to the USaccessdata.fda.gov
Post, Root CanalELR1Exporter to the USaccessdata.fda.gov
Powder, PorcelainEIH2Exporter to the USaccessdata.fda.gov
Retainer, MatrixJEP1Exporter to the USaccessdata.fda.gov
Retractor, All TypesEIG1Exporter to the USaccessdata.fda.gov
Scaler, PeriodonticEMN1Exporter to the USaccessdata.fda.gov
Scissors, Orthopedic, SurgicalHRR1Exporter to the USaccessdata.fda.gov
Suture, Absorbable, Synthetic, Polyglycolic AcidGAM2Exporter to the USaccessdata.fda.gov
Suture, Nonabsorbable, SilkGAP2Exporter to the USaccessdata.fda.gov
Suture, Nonabsorbable, Synthetic, PolyamideGAR2Exporter to the USaccessdata.fda.gov
Suture, Nonabsorbable, Synthetic, PolyethyleneGAT2Exporter to the USaccessdata.fda.gov
Suture, Nonabsorbable, Synthetic, PolypropyleneGAW2Exporter to the USaccessdata.fda.gov
Suture, Surgical, Absorbable, PolydioxanoneNEW2Exporter to the USaccessdata.fda.gov
Syringe, EntKCP1Exporter to the USaccessdata.fda.gov
Syringe, Periodontic, Endodontic, IrrigatingEIC1Exporter to the USaccessdata.fda.gov
System, X-Ray, Extraoral Source, DigitalMUH2Exporter to the USaccessdata.fda.gov
Toothbrush, ManualEFW1Exporter to the USaccessdata.fda.gov
Tray, Fluoride, DisposableKMT1Exporter to the USaccessdata.fda.gov
Tray, Impression, PreformedEHY1Exporter to the USaccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Exporter to the USaccessdata.fda.gov
Tube Impression And MatrixKCQ1Exporter to the USaccessdata.fda.gov
Tubing, NoninvasiveGAZ2Exporter to the USaccessdata.fda.gov
Unit, Operative Dental, AccessoriesNRD1Exporter to the USaccessdata.fda.gov
Unit, Syringe, Air And/Or WaterECB1Exporter to the USaccessdata.fda.gov
Wax, Dental, IntraoralEGD1Exporter to the USaccessdata.fda.gov
Wheel, Polishing AgentEJQ1Exporter to the USaccessdata.fda.gov
Wrap, SterilizationFRG2Exporter 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
August 27, 2025K251716Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl CitrateLZASubstantially EquivalentBasic Medical Technology, Inc.accessdata.fda.gov
June 10, 2025K250735Dental Barrier and SleevesPEMSubstantially EquivalentFomed Industries, Inc.accessdata.fda.gov
February 18, 2025K243792Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate (Black,White)LZASubstantially EquivalentBasic Medical Technology, Inc.accessdata.fda.gov
January 31, 2025K243441Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (Light blue, Dark blue)LZASubstantially EquivalentBasic Medical Technology, Inc.accessdata.fda.gov
July 3, 2023K230487Dental Lithium Disilicate Glass-CeramicEIHSubstantially EquivalentFuzhou Rick Brown Biomaterials Co., Ltd.accessdata.fda.gov
February 13, 2023K221875Sterilization Pouch and RollFRGSubstantially EquivalentQianjiang Kingphar Medical Packaging & Printing Co., Ltd.accessdata.fda.gov
July 19, 2022K220777Surgical face maskFXXSubstantially EquivalentHubei Qianjiang Kingphar Medical Material Co., Ltd.accessdata.fda.gov
April 25, 2022K220512Disposable Surgical Face Mask (M01, M02)FXXSubstantially EquivalentFomed Industries, Inc.accessdata.fda.gov
December 31, 2019K192444mCare® Powder Free Nitrile Black Examination GloveLZASubstantially EquivalentMercator Medical (Thailand), Ltd.accessdata.fda.gov
December 9, 2019K181900Dental high speed handpiece, Dental low speed handpieceEFBSubstantially EquivalentFoshan Cicada Dental Instrument Co, Ltd.accessdata.fda.gov
April 13, 2018K172930mCare Powder-free Blue Nitrile Examination GlovesLZASubstantially EquivalentMercator Medical (Thailand), Ltd.accessdata.fda.gov
April 28, 2017K162258Self Sealing Sterilization PouchesFRGSubstantially EquivalentTianchang Jiarui Packaging Material Co., Ltd.accessdata.fda.gov
September 9, 2015K143637U&U Sterilization Pouch and RollFRGSubstantially EquivalentU&U Medical Technology Co, Ltd.accessdata.fda.gov
September 6, 2013K131442FIRECR DENTALIMAGING SYSTEMMUHSubstantially Equivalent3Disc Americasaccessdata.fda.gov
May 23, 2012K112800SUNTOUCH TOPICAL HEMOSTATIC DRESSINGQSYSubstantially EquivalentHuizhou Foryou Medical Devices Co., Ltd.accessdata.fda.gov
June 9, 2008K080684WG-SURGICAL SUTURES WITH NEEDLEGAPSubstantially EquivalentFoosin Medical Supplies, Inc.accessdata.fda.gov
April 30, 2008K073614WG-SURGICAL SUTURES WITH NEEDLENEWSubstantially EquivalentFoosin Medical Supplies, Inc.accessdata.fda.gov
December 27, 2007K071886SELF SEAL STERILIZATION POUCHFRGSubstantially EquivalentShanghai Jianzhong Medical Packaging Co., Ltd.accessdata.fda.gov
April 23, 1987K870147CARERITE & COST RITE NYLON STERILIZATION FILMFRGSubstantially EquivalentCost Rite Health Products, Inc.accessdata.fda.gov

Compare with other makers

Updated August 27, 2025. 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.