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Data / Medical devices / Germany / Heine Optotechnik GMBH & Co. KG.

Heine Optotechnik GMBH & Co. KG.: FDA-registered device maker in GILCHING Bavaria, Germany, 6 510(k) clearances

Heine Optotechnik GMBH & Co. KG. is registered with the FDA (registration 1000379039) in GILCHING Bavaria, Germany. It lists 22 device types. The FDA files 6 510(k) clearances under its listings, the newest dated May 18, 2015. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch Heine Optotechnik GMBH & Co. KG.
FDA registration number
1000379039
Address
Dornierstr. 6, GILCHING Bavaria, Germany, D-82205
Owner or operator
HEINE OPTOTECHNIK GMBH & CO. KG. (9003020)
Roles
Manufacturer
First device listed
August 8, 1991
Registered through
2027
Brand names listed
Beta, Direct or Indirect Ophthalmoscopes, Handheld Indirect Ophthalmoscope, K180, Monocular, Binocular, Omega, Sigma, UniSpec Disposable Tubes and more

Devices it lists

DeviceProduct codeClassRoleSource
Anoscope And AccessoriesFER2Manufactureraccessdata.fda.gov
Blood Pressure CuffDXQ2Manufactureraccessdata.fda.gov
Chart, Visual AcuityHOX1Manufactureraccessdata.fda.gov
Depressor, Tongue, Non-SurgicalFMA1Manufactureraccessdata.fda.gov
Device, Medical Examination, Ac PoweredKZF1Manufactureraccessdata.fda.gov
Endoscope, RigidGCM2Manufactureraccessdata.fda.gov
Headlamp, Operating, Battery-OperatedHPP1Manufactureraccessdata.fda.gov
Headlight, Fiberoptic FocusingFCT2Manufactureraccessdata.fda.gov
Laryngoscope, RigidCCW1Manufactureraccessdata.fda.gov
Lens, Condensing, DiagnosticHJL1Manufactureraccessdata.fda.gov
Light, Examination, Medical, Battery PoweredKYT1Manufactureraccessdata.fda.gov
Loupe, Binocular, Low PowerHJH1Manufactureraccessdata.fda.gov
Ophthalmoscope, Ac-PoweredHLI2Manufactureraccessdata.fda.gov
Ophthalmoscope, Battery-PoweredHLJ2Manufactureraccessdata.fda.gov
OtoscopeERA1Manufactureraccessdata.fda.gov
Retinoscope, Battery-PoweredHKM1Manufactureraccessdata.fda.gov
Speculum, EntEPY1Manufactureraccessdata.fda.gov
Stand, Instrument, Ac-Powered, OphthalmicHMF1Manufactureraccessdata.fda.gov
Stethoscope, ManualLDE1Manufactureraccessdata.fda.gov
System, Measurement, Blood-Pressure, Non-InvasiveDXN2Manufactureraccessdata.fda.gov
Transilluminator, Ac-PoweredHJM2Manufactureraccessdata.fda.gov
Transilluminator, Battery-PoweredHJN1Manufactureraccessdata.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
May 18, 2015K142486HEINE BETA 200, HEINE BETA 200 S, HEINE K 180HLJSubstantially EquivalentHeine Optotechnik GmbH & Co. KGaccessdata.fda.gov
January 29, 2015K142837HEINE SIGMA 250 & HEINE SIGMA 250 M2HLJSubstantially EquivalentHeine Optotechnik GmbH & Co. KGaccessdata.fda.gov
March 7, 2014K131959HEINE MINI 3000(R) OPHTHALMOSCOPEHLJSubstantially EquivalentHeine Optotechnik GmbH & Co. KGaccessdata.fda.gov
March 22, 2013K123587HEINE MINI 3000 LED OPHTHALMOSCOPEHLJSubstantially EquivalentHeine Optotechnik GmbH & Co. KGaccessdata.fda.gov
February 26, 2013K123316HEINE OMEGA 500HLISubstantially EquivalentHeine Optotechnik GmbH & Co. KGaccessdata.fda.gov
August 27, 2010K101892HEINE GAMMA G7; HEINE GAMMA G5, HEINE GAMMA GP, HEINE GAMMA GST, HEINE GAMMA XXL LF MODEL M-000.09.23X, M-000.09.24X, M-DXQSubstantially EquivalentHeine Optotechnik GmbH & Co. KGaccessdata.fda.gov

Compare with other makers

Updated May 18, 2015. 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.