Heidelberg Engineering G M B H

FDA Filings

This page includes the latest FDA filings for Heidelberg Engineering G M B H. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number8043762
FEI Number3002807157
NameHEIDELBERG ENGINEERING GMBH
Owner & OperatorHeidelberg Engineering GmbH
Contact AddressMax-Jarecki-Str. 8
Heidelberg DE-BW Baden-Wurttemberg 69115 DE
Official Correspondent
  • Thomas Diesch
  • 049-622-164630-294
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressMax-Jarecki-Str. 8
HEIDELBERG Baden-Wurttemberg, 69115 DE
Establishment Type
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198



Registration Number2085838
FEI Number3000204964
NameHEIDELBERG ENGINEERING U.S. Coprorate Office
Owner & OperatorHEIDELBERG ENGINEERING GMBH
Contact AddressMax-Jarecki-Str. 8
Heidelberg DE-BW Baden-Wurttemberg 69115 DE
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address10 Forge Pkwy
Franklin, MA 02038 US



FDA Filings

Device
Company
DeviceDate
Heidelberg Engineering GmbH
Spectralis HRA+OCT And Variants2020-09-09
Heidelberg Engineering GmbH
HEP 2020-03-13
Heidelberg Engineering GmbH
SPECTRALIS 2020-01-29
Heidelberg Engineering GmbH
SPECTRALIS 2020-01-29
Heidelberg Engineering GmbH
SPECTRALIS 2019-11-06
HEIDELBERG ENGINEERING GMBH
SPECTRALIS HRA+OCT and variants2019-10-14
HEIDELBERG ENGINEERING GMBH
SPECTRALIS HRA+OCT and variants2019-10-14
Heidelberg Engineering GmbH
Spectralis HRA+OCT And Variants2019-09-26
Heidelberg Engineering GmbH
SPECTRALIS 2019-05-01
Heidelberg Engineering GmbH
SPECTRALIS 2019-05-01
Heidelberg Engineering GmbH
HRT3 2019-02-18
Heidelberg Engineering GmbH
HRT3 2019-02-18
Heidelberg Engineering GmbH
SPECTRALIS 2019-02-04
Heidelberg Engineering GmbH
SPECTRALIS 2019-02-04
Heidelberg Engineering GmbH
SPECTRALIS 2019-02-04
Heidelberg Engineering GmbH
SPECTRALIS 2019-02-04
HEIDELBERG ENGINEERING GMBH
SPECTRALIS HRA+OCT with High Magnification Module2018-10-22
HEIDELBERG ENGINEERING GMBH
SPECTRALIS HRA+OCT with High Magnification Module2018-10-22
Heidelberg Engineering GmbH
Spectralis HRA+OCT And Variants With High Magnification Module2018-10-18
HEIDELBERG ENGINEERING GMBH
SPECTRALIS HRA+OCT and variants with OCT Angiography Module2018-09-19
HEIDELBERG ENGINEERING GMBH
SPECTRALIS HRA+OCT and variants with OCT Angiography Module2018-09-19
Heidelberg Engineering GmbH
Spectralis HRA+OCT And Variants With OCT Angiography Module2018-09-13
Heidelberg Engineering GmbH
SPECTRALIS 2018-09-07
HEIDELBERG ENGINEERING GMBH
Spectralis HRA + OCT and variants2018-09-04
HEIDELBERG ENGINEERING GMBH
Spectralis HRA + OCT and variants2018-09-04
Heidelberg Engineering GmbH
Spectralis HRA + OCT And Variants2018-08-30
Heidelberg Engineering GmbH
SPECTRALIS, HEP 2018-08-13
Heidelberg Engineering GmbH
SPECTRALIS 2018-08-13
Heidelberg Engineering GmbH
SPECTRALIS 2018-08-13
HEIDELBERG ENGINEERING GMBH
Spectralis HRA + OCT and variants2018-07-09
HEIDELBERG ENGINEERING GMBH
Spectralis HRA + OCT and variants2018-07-09
Heidelberg Engineering GmbH
SPECTRALIS 2018-07-06
Heidelberg Engineering GmbH
SPECTRALIS 2018-07-06
Heidelberg Engineering GmbH
SPECTRALIS 2018-07-06
Heidelberg Engineering GmbH
SPECTRALIS 2018-07-06
Heidelberg Engineering GmbH
SPECTRALIS 2018-07-06
Heidelberg Engineering GmbH
SPECTRALIS 2018-07-06
Heidelberg Engineering GmbH
SPECTRALIS 2018-07-06
Heidelberg Engineering GmbH
SPECTRALIS 2018-07-06
Heidelberg Engineering GmbH
SPECTRALIS 2018-07-06
Heidelberg Engineering GmbH
SPECTRALIS 2018-07-06
Heidelberg Engineering GmbH
SPECTRALIS 2018-07-06
Heidelberg Engineering GmbH
SPECTRALIS 2018-07-06
Heidelberg Engineering GmbH
SPECTRALIS 2018-07-06
Heidelberg Engineering GmbH
SPECTRALIS 2018-07-06
Heidelberg Engineering GmbH
SPECTRALIS 2018-07-06
Heidelberg Engineering GmbH
SPECTRALIS 2018-07-06
Heidelberg Engineering GmbH
SPECTRALIS 2018-07-06
Heidelberg Engineering GmbH
HRT3 2018-03-29
Heidelberg Engineering GmbH
SPECTRALIS, HRT3, HEP 2018-03-29
Heidelberg Engineering GmbH
Spectralis HRA + OCT And Variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT With Multicolor2017-11-01
HEIDELBERG ENGINEERING GMBH
SPECTRALIS HRA+OCT and variants2016-09-01
HEIDELBERG ENGINEERING GMBH
SPECTRALIS HRA+OCT and variants2016-09-01
Heidelberg Engineering GmbH
Spectralis HRA + OCT And Variants (e.g.s Below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT Ith Multicolor2016-05-06
HEIDELBERG ENGINEERING GMBH
Spectralis HRA+OCT MULTICOLOR OPTION2012-11-01
HEIDELBERG ENGINEERING GMBH
Spectralis Anterior Segment Module2012-10-28
HEIDELBERG ENGINEERING GMBH
Spectralis Anterior Segment Module2012-10-28
HEIDELBERG ENGINEERING GMBH
SPECTRALIS HRA + OCT AND VARIANTS, SPECTRALIS FA+ OCT, SPECTRALIS ICGA +OCT, SPECTRALIS OCT BLUE PEAK, SPECTRALIS OCT2012-10-25
HEIDELBERG ENGINEERING GMBH
SPECTRALIS ANTERIOR SEGMENT MODULE (SPECTRALIS ASM)2011-11-08
HEIDELBERG ENGINEERING GMBH
Spectralis OCT2010-12-30
HEIDELBERG ENGINEERING GMBH
Spectralis OCT BluePeak2010-12-30
HEIDELBERG ENGINEERING GMBH
Spectralis HRA2010-12-30
HEIDELBERG ENGINEERING GMBH
Spectralis HRA+OCT2010-12-30
HEIDELBERG ENGINEERING GMBH
Spectralis OCT2010-12-30
HEIDELBERG ENGINEERING GMBH
Spectralis OCT BluePeak2010-12-30
HEIDELBERG ENGINEERING GMBH
Spectralis HRA2010-12-30
HEIDELBERG ENGINEERING GMBH
Spectralis HRA+OCT2010-12-30
HEIDELBERG ENGINEERING GMBH
Heidelberg Retina Angiograph2007-12-05
HEIDELBERG ENGINEERING GMBH
FA/ICGA2007-12-05
HEIDELBERG ENGINEERING GMBH
Heidelberg Retina Angiograph2007-12-05
HEIDELBERG ENGINEERING GMBH
and Flowmeter2007-12-05
HEIDELBERG ENGINEERING GMBH
Heidelberg Retina Tomograph2007-12-05
HEIDELBERG ENGINEERING GMBH
Heidelberg Retina Flowmeter2007-12-05
HEIDELBERG ENGINEERING GMBH
HRF2007-12-05
HEIDELBERG ENGINEERING GMBH
Heidelberg Retina Tomograph2007-12-05
HEIDELBERG ENGINEERING GMBH
SL-OCT2006-11-16
HEIDELBERG ENGINEERING GMBH
Rostock Cornea Module2006-11-16
HEIDELBERG ENGINEERING GMBH
RCM2006-11-16
HEIDELBERG ENGINEERING GMBH
SPECTRALIS HRA-OCT1994-10-11

Related Finance Registrations
NCAGE CodeC7986HEIDELBERG ENGINEERING GMBH
CAGE CodeC7986HEIDELBERG ENGINEERING GMBH OPTISCHE MESSSYSTEME GMBH

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