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Data / Medical devices / Taiwan / R&R Medical Corporation Ltd.

R&R Medical Corporation Ltd.: FDA-registered device maker in Sanchong District New Taipei, Taiwan, 2 510(k) clearances

R&R Medical Corporation Ltd. is registered with the FDA (registration 3010409218) in Sanchong District New Taipei, Taiwan. It lists 24 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 28, 2023. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3010409218
Address
No.4 Lane 38 ZhongXing North Street, Sanchong District New Taipei, Taiwan, 24158
Owner or operator
TAIWAN STANCH CO., LTD. (9026133)
Roles
Complaint file establishment, Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler
First device listed
May 23, 1996
Registered through
2026
Brand names listed
Latest Medical Face Mask, X-Y Lubricating Jelly

Devices it lists

DeviceProduct codeClassRoleSource
Accessory, Surgical ApparelLYU1Manufactureraccessdata.fda.gov
Adhesive Backed Thermal Skin PatchesOMW1Manufactureraccessdata.fda.gov
Bag, IceKYR1Manufactureraccessdata.fda.gov
Bath, Sitz, NonpoweredKTC1Manufactureraccessdata.fda.gov
Bottle, Hot/Cold WaterFPF1Manufactureraccessdata.fda.gov
Cushion, FlotationKIC1Manufactureraccessdata.fda.gov
Douche Apparatus, Vaginal, TherapeuticHED1Manufactureraccessdata.fda.gov
Enema KitFCE1Manufactureraccessdata.fda.gov
Insoles, MedicalKYS1Manufactureraccessdata.fda.gov
Joint, Ankle, External BraceITW1Manufactureraccessdata.fda.gov
Joint, Knee, External BraceITQ1Manufactureraccessdata.fda.gov
Lubricant, PersonalNUC2Complaint file establishment, Exporter to the US, Foreign private label distributor, Manufactureraccessdata.fda.gov
Mask, SurgicalFXX2Foreign private label distributor, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Mattress, Flotation Therapy, Non-PoweredIKY1Manufactureraccessdata.fda.gov
Mattress, Water, Temperature RegulatedFOH1Manufactureraccessdata.fda.gov
Orthosis, CervicalIQK1Manufactureraccessdata.fda.gov
Orthosis, Limb BraceIQI1Manufactureraccessdata.fda.gov
Pack, Hot Or Cold, DisposableIMD1Manufactureraccessdata.fda.gov
Pack, Hot Or Cold, ReusableIME1Manufactureraccessdata.fda.gov
Sling, Arm, Overhead SupportedILE1Manufactureraccessdata.fda.gov
Splint, Extremity, Inflatable, ExternalFZF1Manufactureraccessdata.fda.gov
Splint, Hand, And ComponentsILH1Manufactureraccessdata.fda.gov
Support, ArmIOY1Manufactureraccessdata.fda.gov
UrinalFNP1Manufactureraccessdata.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
March 28, 2023K220226X-Y Lubricating JellyNUCSubstantially EquivalentR&R Medical Corporation, Ltd.accessdata.fda.gov
September 13, 2022K214035LAITEST Medical Face MaskFXXSubstantially EquivalentR&R Medical Corporation, Ltd.accessdata.fda.gov

Compare with other makers

Updated March 28, 2023. 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.