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Data / Medical devices / China / Lianyungang Tiannuo Optical Instrument Co., Ltd.

Lianyungang Tiannuo Optical Instrument Co., Ltd.: FDA-registered device maker in LIANYUNGANG Jiangsu, China, 3 510(k) clearances

Lianyungang Tiannuo Optical Instrument Co., Ltd. is registered with the FDA (registration 3004095901) in LIANYUNGANG Jiangsu, China. It lists 31 device types. The FDA files 3 510(k) clearances under its listings, the newest dated April 15, 2016. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3004095901
Address
No.3 Jinqiao Road, Dapu Industrial Park, LIANYUNGANG Jiangsu, China, 222000
Owner or operator
LIANYUNGANG TIANNUO OPTICAL INSTRUMENT CO., LTD. (9057405)
Roles
Contract manufacturer, Manufacturer, Repackager or relabeler
First device listed
July 14, 2003
Registered through
2026
Brand names listed
1. Portable Slit Lamp Microscope, Model: BL-5000, BL-5100, Confirmation Test, Confirmation Test Flipper, Diopter lens; Retina Lens; Aspheric lens; Bio Lens; Slit Lamp Lens; Non-contact Surgical Lens; Retinal Scale;, EXOPHTHALMOMETER, HKY - Tonometer, manual, Hand-held Keratometer, INCLUDING PHOROPTER OPHTHALMOLOGY and more

Devices it lists

DeviceProduct codeClassRoleSource
Biomicroscope, Slit-Lamp, Ac-PoweredHJO2Repackager or relabeleraccessdata.fda.gov
Biomicroscope, Slit-Lamp, Ac-Powered, ExemptPUE2Repackager or relabeleraccessdata.fda.gov
Chair, Ophthalmic, Ac-PoweredHME1Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Chart, Visual AcuityHOX1Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Clip, Lens, Trial, OphthalmicHPB1Manufactureraccessdata.fda.gov
ExophthalmometerHLS1Manufactureraccessdata.fda.gov
Frame, SpectacleHQZ1Repackager or relabeleraccessdata.fda.gov
Frame, Trial, OphthalmicHPA1Manufactureraccessdata.fda.gov
Gauge, Lens, OphthalmicHLN1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Instrument, Measuring, Lens, Ac-PoweredHLM1Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Keratoscope, Ac-PoweredHLQ1Repackager or relabeleraccessdata.fda.gov
Keratoscope, Battery-PoweredHLR1Repackager or relabeleraccessdata.fda.gov
Lens, Condensing, DiagnosticHJL1Manufactureraccessdata.fda.gov
Lens, MaddoxHKR1Manufactureraccessdata.fda.gov
Lens, Spectacle, Non-Custom (Prescription)HQG1Manufactureraccessdata.fda.gov
Ophthalmoscope, Ac-PoweredHLI2Repackager or relabeleraccessdata.fda.gov
Ophthalmoscope, Battery-PoweredHLJ2Repackager or relabeleraccessdata.fda.gov
Ophthalmoscopes, Replacement Batteries, Hand-HeldMSG2Repackager or relabeleraccessdata.fda.gov
Prism, Bar, OphthalmicHKW1Manufactureraccessdata.fda.gov
Projector, OphthalmicHOS1Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Pupillometer, ManualHLH1Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Rack, SkiascopicHMH1Manufactureraccessdata.fda.gov
Refractometer, OphthalmicHKO1Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Refractor, Manual, Non-Powered, Including PhoropterHKN1Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Retinoscope, Battery-PoweredHKM1Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Set, Lens, Trial, OphthalmicHPC1Manufactureraccessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)HOY1Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Simulatan (Including Crossed Cylinder)HOR1Manufactureraccessdata.fda.gov
Stand, Instrument, Ac-Powered, OphthalmicHMF1Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Table, Instrument, Powered, OphthalmicHRJ1Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Tonometer, ManualHKY2Repackager or relabeleraccessdata.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 15, 2016K142263Applanation TonometerHKYSubstantially EquivalentShanghai Mediworks Precision Instruments Co. , Ltd.accessdata.fda.gov
July 16, 2010K100439MEDIWORKS SLIT LAMPHJOSubstantially EquivalentShanghai Mediworks Precision Instruments Co. , Ltd.accessdata.fda.gov
December 4, 2003K033190VISION-TECH YZ SLIT LAMP, MODEL 66HJOSubstantially EquivalentSuzhou 66 Vision-Tech Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated April 15, 2016. 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.