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Heidelberg Engineering GMBH: FDA-registered device maker in HEIDELBERG Baden-Wurttemberg, Germany, 6 510(k) clearances

Name: Heidelberg Engineering GMBH FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Heidelberg Engineering GMBH is registered with the FDA (registration 8043762) in HEIDELBERG Baden-Wurttemberg, Germany. It lists 5 device types. The FDA files 6 510(k) clearances under its listings, the newest dated September 11, 2026. 2 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 8043762
FEI number: 3002807157
Address: Max-Jarecki-Str. 8, HEIDELBERG Baden-Wurttemberg, Germany, 69115
Owner or operator: Heidelberg Engineering GmbH (9003668)
Roles: Manufacturer
First device listed: November 16, 2006
Registered through: 2027
Brand names listed: ANTERION, HEYEX 2 / HEYEX PACS, SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module, Spectralis Anterior Segment Module, TOMOCAP

Devices it lists

Device	Product code	Class	Role	Source
Device, Analysis, Anterior Segment	MXK	2	Manufacturer	accessdata.fda.gov
Ophthalmoscope, Laser, Scanning	MYC	2	Manufacturer	accessdata.fda.gov
System, Image Management, Ophthalmic	NFJ	2	Manufacturer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Manufacturer	accessdata.fda.gov
Tomography, Optical Coherence	OBO	2	Manufacturer	accessdata.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.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 11, 2026	K261019	ANTERION	OBO	Substantially Equivalent	Heidelberg Engineering GmbH	accessdata.fda.gov
May 7, 2026	K253837	SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module	OBO	Substantially Equivalent	Heidelberg Engineering GmbH	accessdata.fda.gov
December 13, 2024	K240924	Anterion	OBO	Substantially Equivalent	Heidelberg Engineering GmbH	accessdata.fda.gov
February 18, 2020	K200132	Ashvins	LLZ	Substantially Equivalent	Medicalcommunications GmbH	accessdata.fda.gov
November 8, 2011	K113129	SPECTRALIS ANTERIOR SEGMENT MODULE (SPECTRALIS ASM)	OBO	Substantially Equivalent	Heidelberg Engineering GmbH	accessdata.fda.gov
October 13, 2004	K042742	HEIDELBERG RETINA TOMOGRAPH II / ROSTOCK CORNEA MODULE (HRT II / RCM)	MXK	Substantially Equivalent	Heidelberg Engineering	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
August 6, 2026	99595	Class II	Ongoing	Brand Name: Heidelberg Engineering GmbH Product Name: SPECTRALIS with Flex Module Model/Catalog Number: S3610, S2610, S2000, S1610 multimodal imaging platform optimized for the posterior segment of the eye	Wheels may come loose when module is being pushed or pulled during movement or transportation, affecting stability of the stand. The stand may tip over as a result. Falling stand may cause impact or crushing injuries, particularly to the feet, legs, hands or arms of the operator or nearby persons.	accessdata.fda.gov
July 3, 2019	83568	Class II	Terminated	SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic imaging device.	Error in the default configuration which could lead to the incorrect display of patient master data.	accessdata.fda.gov

Compare with other makers

Updated September 18, 2026. 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.