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Data / Medical devices / Taiwan / Valentine Intl. Ltd.

Valentine Intl. Ltd.: FDA-registered device maker in Hsichih City, Taipei Hsien, Taiwan, 7 510(k) clearances

Valentine Intl. Ltd. is registered with the FDA (registration 8022890) in Hsichih City, Taipei Hsien, Taiwan. It lists 101 device types. The FDA files 7 510(k) clearances under its listings, the newest dated September 16, 2011. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
8022890
FEI number
3926
Address
8TH FL., No. 149, Sec. 2, Ta Tung RD., Hsichih City, Taipei Hsien, Taiwan, 221
Owner or operator
VALENTINE INTL. LTD. (8022890)
Roles
Exporter to the US, Manufacturer, Remanufacturer
First device listed
August 2, 1990
Registered through
2026
Brand names listed
AC Powered Bed, ACCESSORIES, WHEELCHAIR, APPLICATOR, ABSORBENT TIPPED, NON-STERILE, ARMREST, WHEELCHAIR, ATTACHMENT, COMMODE, WHEELCHAIR, BAG, DRAINAGE, WITH ADHESIVE, OSTOMY, BLADE, SCALPEL, BOTTLE, HOT/COLD WATER and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, WheelchairKNO1Exporter to the US, Manufactureraccessdata.fda.gov
Accessory, Surgical ApparelLYU1Exporter to the US, Manufactureraccessdata.fda.gov
Adaptor, DressingILD1Exporter to the US, Manufactureraccessdata.fda.gov
Adaptor, HygieneILS1Exporter to the US, Manufactureraccessdata.fda.gov
Aid, TransferIKX1Exporter to the US, Manufactureraccessdata.fda.gov
Apparatus, Traction, Non-PoweredHST1Exporter to the US, Manufactureraccessdata.fda.gov
Applicator, Absorbent Tipped, Non-SterileKXF1Exporter to the US, Manufactureraccessdata.fda.gov
Armrest, WheelchairIML1Exporter to the US, Manufactureraccessdata.fda.gov
Attachment, Commode, WheelchairINB1Exporter to the US, Manufactureraccessdata.fda.gov
Bag, Drainage, With Adhesive, OstomyFON1Exporter to the US, Manufactureraccessdata.fda.gov
Bag, IceKYR1Exporter to the US, Manufactureraccessdata.fda.gov
Bag, Urine Collection, Leg, For External Use, Non-SterileNNW1Exporter to the US, Manufactureraccessdata.fda.gov
Bandage, ElasticFQM1Exporter to the US, Manufactureraccessdata.fda.gov
Bath, Sitz, NonpoweredKTC1Exporter to the US, Manufactureraccessdata.fda.gov
Bed, Ac-Powered Adjustable HospitalFNL2Exporter to the US, Manufactureraccessdata.fda.gov
Bed, ManualFNJ1Exporter to the US, Manufactureraccessdata.fda.gov
Bedding, Disposable, MedicalKME1Exporter to the US, Manufactureraccessdata.fda.gov
BedpanFOB1Exporter to the US, Manufactureraccessdata.fda.gov
Belt, WheelchairIQB1Exporter to the US, Manufactureraccessdata.fda.gov
Blade, ScalpelGES1Exporter to the US, Manufactureraccessdata.fda.gov
Blood Pressure CuffDXQ2Exporter to the US, Manufactureraccessdata.fda.gov
Board, BedFPS1Exporter to the US, Manufactureraccessdata.fda.gov
Bottle, Hot/Cold WaterFPF1Exporter to the US, Manufactureraccessdata.fda.gov
CaneIPS1Exporter to the US, Manufactureraccessdata.fda.gov
Cannula, Nasal, OxygenCAT1Exporter to the US, Manufactureraccessdata.fda.gov
Cannulae, BronchialKCE1Exporter to the US, Manufactureraccessdata.fda.gov
Chair And Table, MedicalKMN1Exporter to the US, Manufactureraccessdata.fda.gov
Chair, Adjustable, MechanicalINN1Exporter to the US, Manufactureraccessdata.fda.gov
Chair, With CastersINM1Exporter to the US, Manufactureraccessdata.fda.gov
Component, External, Limb, Ankle/FootISH1Exporter to the US, Manufactureraccessdata.fda.gov
Component, Traction, Non-InvasiveKQZ1Exporter to the US, Manufactureraccessdata.fda.gov
Components, WheelchairKNN1Exporter to the US, Manufactureraccessdata.fda.gov
Compressor, Air, PortableBTI2Exporter to the US, Manufactureraccessdata.fda.gov
Container, Liquid Medication, GraduatedKYW1Exporter to the US, Manufactureraccessdata.fda.gov
Cover, CastKIA1Exporter to the US, Manufactureraccessdata.fda.gov
Cover, LimbIPM1Exporter to the US, Manufactureraccessdata.fda.gov
Cover, Mattress (Medical Purposes)FMW1Exporter to the US, Manufactureraccessdata.fda.gov
Cover, Shoe, Operating-RoomFXP1Exporter to the US, Manufactureraccessdata.fda.gov
CrutchIPR1Exporter to the US, Manufactureraccessdata.fda.gov
Cushion, FlotationKIC1Exporter to the US, Manufactureraccessdata.fda.gov
Cushion, WheelchairIMP1Exporter to the US, Manufactureraccessdata.fda.gov
Depressor, Tongue, Non-SurgicalFMA1Exporter to the US, Manufactureraccessdata.fda.gov
Device, Incontinence, Urosheath Type, Non-SterileNNX1Exporter to the US, Manufactureraccessdata.fda.gov
Device, Transfer, Patient, ManualFMR1Exporter to the US, Manufactureraccessdata.fda.gov
Dispenser, Liquid MedicationKYX1Exporter to the US, Manufactureraccessdata.fda.gov
Dispenser, Solid MedicationNXB1Exporter to the US, Manufactureraccessdata.fda.gov
Dynamometer, NonpoweredHRW1Exporter to the US, Manufactureraccessdata.fda.gov
Electrode, CutaneousGXY2Exporter to the US, Manufactureraccessdata.fda.gov
Exerciser, MeasuringISD2Exporter to the US, Manufactureraccessdata.fda.gov
Exerciser, Non-MeasuringION1Exporter to the US, Manufactureraccessdata.fda.gov
Footrest, WheelchairIMM1Exporter to the US, Manufactureraccessdata.fda.gov
Gauge, MeasuringJYJ1Exporter to the US, Manufactureraccessdata.fda.gov
Halter, Head, TractionHSS1Exporter to the US, Manufactureraccessdata.fda.gov
Headrest, NeurosurgicalHBM1Exporter to the US, Manufactureraccessdata.fda.gov
Holder, Crutch And Cane, WheelchairIMZ1Exporter to the US, Manufactureraccessdata.fda.gov
Hook, External Limb Component, MechanicalIQX1Exporter to the US, Manufactureraccessdata.fda.gov
Insoles, MedicalKYS1Exporter to the US, Manufactureraccessdata.fda.gov
Lift, Patient, Non-Ac-PoweredFSA1Exporter to the US, Manufactureraccessdata.fda.gov
Light, Examination, Medical, Battery PoweredKYT1Exporter to the US, Manufactureraccessdata.fda.gov
Magnifier, Hand-Held, Low-VisionHJF1Exporter to the US, Manufactureraccessdata.fda.gov
Mask, ScavengingKHA1Manufactureraccessdata.fda.gov
Mask, SurgicalFXX2Manufactureraccessdata.fda.gov
Massager, Therapeutic, ElectricISA1Exporter to the US, Manufactureraccessdata.fda.gov
Massager, Therapeutic, ManualLYG1Exporter to the US, Manufactureraccessdata.fda.gov
Mattress, Air Flotation, Alternating PressureFNM2Exporter to the US, Manufactureraccessdata.fda.gov
Nebulizer (Direct Patient Interface)CAF2Exporter to the US, Manufactureraccessdata.fda.gov
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)CCQ1Manufactureraccessdata.fda.gov
Orthosis, AbdominalKTD1Exporter to the US, Manufactureraccessdata.fda.gov
Orthosis, CervicalIQK1Exporter to the US, Manufactureraccessdata.fda.gov
Orthosis, Limb BraceIQI1Exporter to the US, Manufactureraccessdata.fda.gov
Orthosis, Lumbo-SacralIPY1Exporter to the US, Manufacturer, Remanufactureraccessdata.fda.gov
Orthosis, Rib Fracture, SoftIPX1Exporter to the US, Manufactureraccessdata.fda.gov
Orthosis, Truncal/Orthosis, LimbMRI1Exporter to the US, Manufactureraccessdata.fda.gov
OtoscopeERA1Exporter to the US, Manufactureraccessdata.fda.gov
PercussorGWZ1Exporter to the US, Manufactureraccessdata.fda.gov
Protector, Skin PressureFMP1Exporter to the US, Manufactureraccessdata.fda.gov
Pump, Nebulizer, Electrically PoweredJPW1Exporter to the US, Manufactureraccessdata.fda.gov
Scale, Platform, WheelchairINF1Exporter to the US, Manufactureraccessdata.fda.gov
Scale, Stand-On, PatientFRI1Exporter to the US, Manufactureraccessdata.fda.gov
Sheath, Corrugated Rubber, For Nonindwelling Catheter, SterileEYT1Exporter to the US, Manufactureraccessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)HOY1Exporter to the US, Manufactureraccessdata.fda.gov
Shoe, CastIPG1Exporter to the US, Manufactureraccessdata.fda.gov
Sling, ArmILI1Exporter to the US, Manufactureraccessdata.fda.gov
Sling, Overhead Suspension, WheelchairINE1Exporter to the US, Manufactureraccessdata.fda.gov
Splint, Extremity, Inflatable, ExternalFZF1Exporter to the US, Manufactureraccessdata.fda.gov
Splint, Extremity, Non-Inflatable, External, Non-SterileNOC1Exporter to the US, Manufactureraccessdata.fda.gov
Splint, Extremity, Noninflatable, External, SterileFYH1Exporter to the US, Manufactureraccessdata.fda.gov
Splint, Hand, And ComponentsILH1Exporter to the US, Manufactureraccessdata.fda.gov
Stand, InfusionFOX1Exporter to the US, Manufactureraccessdata.fda.gov
Stethoscope, ManualLDE1Exporter to the US, Manufactureraccessdata.fda.gov
Stimulator, Muscle, PoweredIPF2Exporter to the US, Manufactureraccessdata.fda.gov
Stimulator, Nerve, Transcutaneous, For Pain ReliefGZJ2Exporter to the US, Manufactureraccessdata.fda.gov
Stool, Operating-RoomFZM1Exporter to the US, Manufactureraccessdata.fda.gov
Support GelsJZR1Exporter to the US, Manufactureraccessdata.fda.gov
Table, MechanicalINW1Exporter to the US, Manufactureraccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Exporter to the US, Manufactureraccessdata.fda.gov
Tape, Measuring, Rulers And CalipersFTY1Exporter to the US, Manufactureraccessdata.fda.gov
Tips And Pads, Cane, Crutch And WalkerINP1Exporter to the US, Manufactureraccessdata.fda.gov
UrinalFNP1Exporter to the US, Manufactureraccessdata.fda.gov
Utensil, EatingILC1Exporter to the US, Manufactureraccessdata.fda.gov
Walker, MechanicalITJ1Exporter 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
September 16, 2011K111559SURGICAL MASKSFXXSubstantially EquivalentShanghai Neo-Medical Import & Export Co., Ltd.accessdata.fda.gov
April 9, 2009K090014CAREMATE SPHYGMOMANOMETER WITH STETHOSCOPEDXQSubstantially EquivalentCaremate Medical Device Co., Ltd.accessdata.fda.gov
January 4, 2007K062675GEMORE REUSEABLE SELF ADHESIVE ELECTRODE, MODELS WIRE SERIES, SNAP SERIES AND DOUBLE SIDE SERIESGXYSubstantially EquivalentGemore Technology Co, Ltd.accessdata.fda.gov
June 9, 2006K060871AS101, BLOOD PRESSURE CUFFDXQSubstantially EquivalentWenzhou Longwan Medical Instrument Companyaccessdata.fda.gov
December 10, 2003K032720GEM-STIM TENS, MODELS GM3XY AND GM3AXYGZJSubstantially EquivalentGemore Technology Co, Ltd.accessdata.fda.gov
October 7, 2003K031413VIGORMIST COMPRESSOR NEBULIZERBTISubstantially EquivalentVega Technologies, Inc.accessdata.fda.gov
May 23, 2001K002831VEGA ULTRASONIC NEBULIZERCAFSubstantially EquivalentVega Technologies, Inc.accessdata.fda.gov

Compare with other makers

Updated September 16, 2011. 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.