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HEIDELBERG ENGINEERING GMBH

Matched from indexed company URL: Heidelberg Engineering GmbH

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
80437623002807157HEIDELBERG ENGINEERING GMBH1N2026-01-01Max-Jarecki-Str. 8 HEIDELBERG Baden-Wurttemberg DE 69115

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
444071810259646K971671HEIDELBERG RETINA ANGIOGRAPH FA/ICGA (HRA/C)HLI1997-07-29
444072045231380K944261RETINA ANGIOGRAPHHLI1994-11-14
444071318143969K943956RETINA TOMOGRAPH AND FLOWMETERHLI1994-11-14
444071454145229K943955RETINA FLOWMETERHLI1994-11-14
444072069766919K912891HEIDELBERG RETINA TOMOGRAPHHLI1991-09-27
444071493459568K241163SPECTRALIS with Flex ModuleOBO2024-10-11
444071974026845K240924AnterionOBO2024-12-13
444071499261025K240221SPECTRALIS HRA+OCT and variantsOBO2024-07-01
444071543044949K230897AnterionOBO2023-10-11
444072069960956K223557SPECTRALIS HRA+OCT and variantsOBO2023-10-20
444071278869060K211817AnterionOBO2021-11-05
444071824685225K192391Spectralis HRA+OCT and VariantsOBO2019-09-26
444071785473903K182569Spectralis HRA+OCT and variants with High Magnification ModuleOBO2018-10-18
444071707432326K181594Spectralis HRA+OCT and variants with OCT Angiography ModuleOBO2018-09-13
444071094616950K173648Spectralis HRA + OCT and variantsOBO2018-08-30
444071356358211K172649Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with MulticolorOBO2017-11-01
444071484715856K152205Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT ith MulticolorOBO2016-05-06
444071129854162K121993SPECTRALIS HRA + OCT AND VARIANTS, SPECTRALIS FA+ OCT, SPECTRALIS ICGA +OCT, SPECTRALIS OCT BLUE PEAK, SPECTRALIS OCTOBO2012-10-25
444071433627526K113129SPECTRALIS ANTERIOR SEGMENT MODULE (SPECTRALIS ASM)OBO2011-11-08
444071845473927K101223SPECTRALIS HRA+OCT, SPECTRALIS FA_OCT, SPECTRALIS ICGA+ OCT, SPECTRALIS HRA, SPECTRALIS FAOBO2010-10-01
444071836442814K063191HEIDELBERG RETINA ANGIOGRAPH 2/OPTICAL COHERENCE TOMOGRAPH, MODEL HRA 2/OCTOBO2006-10-31
444071502733819K052935HEIDELBERG ENGINEERING SLITLAMP-OCT (SL-OCT)MXK2006-01-13
444071518194268K042742HEIDELBERG RETINA TOMOGRAPH II / ROSTOCK CORNEA MODULE (HRT II / RCM)MXK2004-10-13

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OBO162024-12-13
HLI51997-07-29
MXK22006-01-13

PMN#

Anterion

2024-12-13

Heidelberg Engineering GmbH

Anterion

2023-10-11

Heidelberg Engineering GmbH

Anterion

2021-11-05

Heidelberg Engineering GmbH

GUDID#

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