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Data / Medical devices / Taiwan / Medimaging Integrated Solution Inc.

Medimaging Integrated Solution Inc.: FDA-registered device maker in Hsinchu Hsinchu(City), Taiwan, 9 510(k) clearances

Medimaging Integrated Solution Inc. is registered with the FDA (registration 3015316279) in Hsinchu Hsinchu(City), Taiwan. It lists 22 device types. The FDA files 9 510(k) clearances under its listings, the newest dated December 23, 2025. 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 Medimaging Integrated Solution Inc.
FDA registration number
3015316279
Address
3F, No.24-2, Industry E. Rd. IV, Hsinchu Science Park, Hsinchu Hsinchu(City), Taiwan, 30077
Owner or operator
Medimaging Integrated Solution Inc. (10037829)
Roles
Contract manufacturer, Exporter to the US, Manufacturer
First device listed
August 23, 2011
Registered through
2026
Brand names listed
MPD 100: MiiS Wound Care System, MiiS horus SCOPE Orthopedics Disposable Trocar Kit (OTM 100), Ophthalmic eye shield

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, ArthroscopicNBH1Manufactureraccessdata.fda.gov
ArthroscopeHRX2Manufactureraccessdata.fda.gov
Biomicroscope, Slit-Lamp, Ac-PoweredHJO2Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Bronchoscope (Flexible Or Rigid)EOQ2Exporter to the US, Manufactureraccessdata.fda.gov
Camera, Ophthalmic, Ac-PoweredHKI2Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Camera, Ophthalmic, General-UsePJZ2Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Camera, Still, SurgicalFTT1Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Cystoscope And Accessories, Flexible/RigidFAJ2Exporter to the US, Manufactureraccessdata.fda.gov
Device, Communications, Images, OphthalmicNFG1Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Light, Examination, Medical, Battery PoweredKYT1Manufactureraccessdata.fda.gov
Loupe, Diagnostic/SurgicalFSP1Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Medical Device Data SystemOUG1Manufactureraccessdata.fda.gov
Nasopharyngoscope (Flexible Or Rigid)EOB2Exporter to the US, Manufactureraccessdata.fda.gov
OtoscopeERA1Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Reminder, MedicationNXQ1Exporter to the US, Manufactureraccessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)HOY1Manufactureraccessdata.fda.gov
Speculum, IlluminatedFXF1Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
System, Digital Image Communications, RadiologicalLMD1Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Tape, Camera, SurgicalFXN1Exporter to the US, Manufactureraccessdata.fda.gov
Tonometer, Ac-PoweredHKX2Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Transilluminator, Battery-PoweredHJN1Manufactureraccessdata.fda.gov
Unit, Operative Dental, AccessoriesNRD1Manufactureraccessdata.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
December 23, 2025K253217MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)HRXSubstantially EquivalentMedimaging Integrated Solution, Inc (Miis)accessdata.fda.gov
May 1, 2024K234113MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus Endoscope Display System -Video BoxEOQSubstantially EquivalentMedimaging Integrated Solution, Inc (Miis)accessdata.fda.gov
November 8, 2023K223739VS Tabletop TonometerHKXSubstantially EquivalentMedimaging Integrated Solution, Inc.accessdata.fda.gov
October 6, 2023K223926VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video BoxFAJSubstantially EquivalentMedimaging Integrated Solution, Inc (Miis)accessdata.fda.gov
July 1, 2022K214050ENT Nasopharyngoscope and AccessoriesEOBSubstantially EquivalentMedimaging Integrated Solution, Inc (Miis)accessdata.fda.gov
January 14, 2020K193188MiiS Horus Eye Anterior CameraHJOSubstantially EquivalentMedimaging Integrated Solution, Inc (Miis)accessdata.fda.gov
June 21, 2019K181260MiiS Horus Scope DPT 100HKXSubstantially EquivalentMedimaging Integrated Solution, Inc (Miis)accessdata.fda.gov
October 6, 2017K170470Digital Eye Anterior CameraHJOSubstantially EquivalentMedimaging Integrated Solution, Inc (Miis)accessdata.fda.gov
September 28, 2012K120982DIGITAL EYE-FUNDUS CAMERAHKISubstantially EquivalentMedimaging Integrated Solutions, Inc. (Miis)accessdata.fda.gov

Compare with other makers

Updated December 23, 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.