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 Number: 8043762
• FEI Number: 3002807157
• Name: HEIDELBERG ENGINEERING GMBH
• Owner & Operator: Heidelberg Engineering GmbH
• Contact Address: Max-Jarecki-Str. 8 ; Heidelberg DE-BW Baden-Wurttemberg 69115 DE
• Official Correspondent:
  • Thomas Diesch
  • 049-622-164630-294
• US Agent:
  • Ricky Lopez
  • HEIDELBERG ENGINEERING, U.S. Corporate Office
  • 508 5317820
  • Ricky.lopez@heidelbergengineering.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Max-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 Number: 2085838
• FEI Number: 3000204964
• Name: HEIDELBERG ENGINEERING U.S. Coprorate Office
• Owner & Operator: HEIDELBERG ENGINEERING GMBH
• Contact Address: Max-Jarecki-Str. 8 ; Heidelberg DE-BW Baden-Wurttemberg 69115 DE
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 10 Forge Pkwy ; Franklin, MA 02038 US

FDA Filings

Device Company	Device	Date
GUDID 04059237000945 Heidelberg Engineering GmbH	ANTERION	2023-11-27
GUDID 04059237000938 Heidelberg Engineering GmbH	ANTERION	2023-11-27
GUDID 04059237000730 Heidelberg Engineering GmbH	HRT3	2023-03-13
GUDID 04059237000891 Heidelberg Engineering GmbH	SPECTRALIS	2022-11-03
GUDID 04059237000884 Heidelberg Engineering GmbH	SPECTRALIS	2022-11-03
GUDID 04059237000877 Heidelberg Engineering GmbH	ANTERION	2022-10-07
GUDID 04059237000754 Heidelberg Engineering GmbH	ANTERION	2022-02-22
GUDID 04059237000839 Heidelberg Engineering GmbH	SPECTRALIS	2022-02-10
GUDID 04059237000815 Heidelberg Engineering GmbH	SPECTRALIS	2022-02-10
GUDID 04059237000617 Heidelberg Engineering GmbH	ANTERION	2022-01-11
PMN K211817 Heidelberg Engineering GmbH	Anterion	2021-11-05
GUDID 04059237000747 Heidelberg Engineering GmbH	TOMOCAP 18829	2020-11-06
PMN K201252 Heidelberg Engineering GmbH	Spectralis HRA+OCT And Variants	2020-09-09
GUDID 04059237000372 Heidelberg Engineering GmbH	HEP	2020-03-13
GUDID 04059237000488 Heidelberg Engineering GmbH	SPECTRALIS	2020-01-29
GUDID 04059237000464 Heidelberg Engineering GmbH	SPECTRALIS	2020-01-29
GUDID 04059237000716 Heidelberg Engineering GmbH	SPECTRALIS	2019-11-06
PMN K192391 | OBO HEIDELBERG ENGINEERING GMBH	SPECTRALIS HRA+OCT and variants	2019-10-14
PMN K192391 | MYC HEIDELBERG ENGINEERING GMBH	SPECTRALIS HRA+OCT and variants	2019-10-14
PMN K192391 Heidelberg Engineering GmbH	Spectralis HRA+OCT And Variants	2019-09-26
GUDID 04059237000594 Heidelberg Engineering GmbH	SPECTRALIS	2019-05-01
GUDID 04059237000570 Heidelberg Engineering GmbH	SPECTRALIS	2019-05-01
GUDID 04059237000273 Heidelberg Engineering GmbH	HRT3	2019-02-18
GUDID 04059237000266 Heidelberg Engineering GmbH	HRT3	2019-02-18
GUDID 04059237000549 Heidelberg Engineering GmbH	SPECTRALIS	2019-02-04
GUDID 04059237000525 Heidelberg Engineering GmbH	SPECTRALIS	2019-02-04
GUDID 04059237000501 Heidelberg Engineering GmbH	SPECTRALIS	2019-02-04
GUDID 04059237000211 Heidelberg Engineering GmbH	SPECTRALIS	2019-02-04
PMN K182569 | OBO HEIDELBERG ENGINEERING GMBH	SPECTRALIS HRA+OCT with High Magnification Module	2018-10-22
PMN K182569 | MYC HEIDELBERG ENGINEERING GMBH	SPECTRALIS HRA+OCT with High Magnification Module	2018-10-22
PMN K182569 Heidelberg Engineering GmbH	Spectralis HRA+OCT And Variants With High Magnification Module	2018-10-18
PMN K181594 | OBO HEIDELBERG ENGINEERING GMBH	SPECTRALIS HRA+OCT and variants with OCT Angiography Module	2018-09-19
PMN K181594 | MYC HEIDELBERG ENGINEERING GMBH	SPECTRALIS HRA+OCT and variants with OCT Angiography Module	2018-09-19
PMN K181594 Heidelberg Engineering GmbH	Spectralis HRA+OCT And Variants With OCT Angiography Module	2018-09-13
GUDID 04059237000136 Heidelberg Engineering GmbH	SPECTRALIS	2018-09-07
PMN K173648 | OBO HEIDELBERG ENGINEERING GMBH	Spectralis HRA + OCT and variants	2018-09-04
PMN K173648 | MYC HEIDELBERG ENGINEERING GMBH	Spectralis HRA + OCT and variants	2018-09-04
PMN K173648 Heidelberg Engineering GmbH	Spectralis HRA + OCT And Variants	2018-08-30
GUDID 04059237000396 Heidelberg Engineering GmbH	SPECTRALIS, HEP	2018-08-13
GUDID 04059237000358 Heidelberg Engineering GmbH	SPECTRALIS	2018-08-13
GUDID 04059237000341 Heidelberg Engineering GmbH	SPECTRALIS	2018-08-13
PMN K172649 | OBO HEIDELBERG ENGINEERING GMBH	Spectralis HRA + OCT and variants	2018-07-09
PMN K172649 | MYC HEIDELBERG ENGINEERING GMBH	Spectralis HRA + OCT and variants	2018-07-09
GUDID 04059237000310 Heidelberg Engineering GmbH	SPECTRALIS	2018-07-06
GUDID 04059237000303 Heidelberg Engineering GmbH	SPECTRALIS	2018-07-06
GUDID 04059237000297 Heidelberg Engineering GmbH	SPECTRALIS	2018-07-06
GUDID 04059237000280 Heidelberg Engineering GmbH	SPECTRALIS	2018-07-06
GUDID 04059237000259 Heidelberg Engineering GmbH	SPECTRALIS	2018-07-06
GUDID 04059237000150 Heidelberg Engineering GmbH	SPECTRALIS	2018-07-06
GUDID 04059237000112 Heidelberg Engineering GmbH	SPECTRALIS	2018-07-06
GUDID 04059237000105 Heidelberg Engineering GmbH	SPECTRALIS	2018-07-06
GUDID 04059237000099 Heidelberg Engineering GmbH	SPECTRALIS	2018-07-06
GUDID 04059237000082 Heidelberg Engineering GmbH	SPECTRALIS	2018-07-06
GUDID 04059237000075 Heidelberg Engineering GmbH	SPECTRALIS	2018-07-06
GUDID 04059237000068 Heidelberg Engineering GmbH	SPECTRALIS	2018-07-06
GUDID 04059237000051 Heidelberg Engineering GmbH	SPECTRALIS	2018-07-06
GUDID 04059237000044 Heidelberg Engineering GmbH	SPECTRALIS	2018-07-06
GUDID 04059237000037 Heidelberg Engineering GmbH	SPECTRALIS	2018-07-06
GUDID 04059237000020 Heidelberg Engineering GmbH	SPECTRALIS	2018-07-06
GUDID 04059237000013 Heidelberg Engineering GmbH	SPECTRALIS	2018-07-06
GUDID 04059237000334 Heidelberg Engineering GmbH	HRT3	2018-03-29
GUDID 04059237000242 Heidelberg Engineering GmbH	SPECTRALIS, HRT3, HEP	2018-03-29
PMN K172649 Heidelberg Engineering GmbH	Spectralis HRA + OCT And Variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT With Multicolor	2017-11-01
PMN K152205 | OBO HEIDELBERG ENGINEERING GMBH	SPECTRALIS HRA+OCT and variants	2016-09-01
PMN K152205 | MYC HEIDELBERG ENGINEERING GMBH	SPECTRALIS HRA+OCT and variants	2016-09-01
PMN K152205 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 Multicolor	2016-05-06
PMN K121993 | OBO HEIDELBERG ENGINEERING GMBH	Spectralis HRA+OCT MULTICOLOR OPTION	2012-11-01
PMN K113129 | OBO HEIDELBERG ENGINEERING GMBH	Spectralis Anterior Segment Module	2012-10-28
PMN K113129 | MYC HEIDELBERG ENGINEERING GMBH	Spectralis Anterior Segment Module	2012-10-28
PMN K121993 HEIDELBERG ENGINEERING GMBH	SPECTRALIS HRA + OCT AND VARIANTS, SPECTRALIS FA+ OCT, SPECTRALIS ICGA +OCT, SPECTRALIS OCT BLUE PEAK, SPECTRALIS OCT	2012-10-25
PMN K113129 HEIDELBERG ENGINEERING GMBH	SPECTRALIS ANTERIOR SEGMENT MODULE (SPECTRALIS ASM)	2011-11-08
PMN K101223 | OBO HEIDELBERG ENGINEERING GMBH	Spectralis OCT	2010-12-30
PMN K101223 | OBO HEIDELBERG ENGINEERING GMBH	Spectralis OCT BluePeak	2010-12-30
PMN K101223 | OBO HEIDELBERG ENGINEERING GMBH	Spectralis HRA	2010-12-30
PMN K101223 | OBO HEIDELBERG ENGINEERING GMBH	Spectralis HRA+OCT	2010-12-30
PMN K101223 | MYC HEIDELBERG ENGINEERING GMBH	Spectralis OCT	2010-12-30
PMN K101223 | MYC HEIDELBERG ENGINEERING GMBH	Spectralis OCT BluePeak	2010-12-30
PMN K101223 | MYC HEIDELBERG ENGINEERING GMBH	Spectralis HRA	2010-12-30
PMN K101223 | MYC HEIDELBERG ENGINEERING GMBH	Spectralis HRA+OCT	2010-12-30
PMN K971671 | HLI HEIDELBERG ENGINEERING GMBH	Heidelberg Retina Angiograph	2007-12-05
PMN K971671 | HLI HEIDELBERG ENGINEERING GMBH	FA/ICGA	2007-12-05
PMN K944261 | HLI HEIDELBERG ENGINEERING GMBH	Heidelberg Retina Angiograph	2007-12-05
PMN K943956 | HLI HEIDELBERG ENGINEERING GMBH	and Flowmeter	2007-12-05
PMN K943956 | HLI HEIDELBERG ENGINEERING GMBH	Heidelberg Retina Tomograph	2007-12-05
PMN K943955 | HLI HEIDELBERG ENGINEERING GMBH	Heidelberg Retina Flowmeter	2007-12-05
PMN K943955 | HLI HEIDELBERG ENGINEERING GMBH	HRF	2007-12-05
PMN K912891 | HLI HEIDELBERG ENGINEERING GMBH	Heidelberg Retina Tomograph	2007-12-05
PMN K052935 | MXK HEIDELBERG ENGINEERING GMBH	SL-OCT	2006-11-16
PMN K042742 | MXK HEIDELBERG ENGINEERING GMBH	Rostock Cornea Module	2006-11-16
PMN K042742 | MXK HEIDELBERG ENGINEERING GMBH	RCM	2006-11-16
PMN K063191 | OBO HEIDELBERG ENGINEERING GMBH	SPECTRALIS HRA-OCT	1994-10-11

Related Finance Registrations

NCAGE Code	C7986	HEIDELBERG ENGINEERING GMBH
CAGE Code	C7986	HEIDELBERG ENGINEERING GMBH OPTISCHE MESSSYSTEME GMBH