HEIDELBERG ENGINEERING GMBH

FDA Device Registration & Listing · HEIDELBERG Baden-Wurttemberg, DE · Registration 8043762

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
8043762
FEI Number
3002807157
Entity Name
HEIDELBERG ENGINEERING GMBH
City/State/Country
HEIDELBERG Baden-Wurttemberg, DE
Establishment Address
Max-Jarecki-Str. 8, HEIDELBERG Baden-Wurttemberg 69115, DE
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Heidelberg Engineering GmbH (Owner Number: 9003668)
Owner / Operator Contact Address
Max-Jarecki-Str. 8, Heidelberg, DE-BW 69115, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K223557
PMA Number
N/A

All Registered Proprietary Names

ANTERION SPECTRALIS HRA+OCT and variants RCM Rostock Cornea Module TOMOCAP SPECTRALIS with Flex Module Spectralis HRA + OCT and variants SPECTRALIS HRA+OCT and variants

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OBO Tomography, Optical Coherence Ophthalmic Class 2 886.1570 2023-10-16
MYC Ophthalmoscope, Laser, Scanning Ophthalmic Class 2 886.1570 2024-09-16
OBO Tomography, Optical Coherence Ophthalmic Class 2 886.1570 2024-09-16
MXK Device, Analysis, Anterior Segment Ophthalmic Class 2 886.1850 2006-11-16
OBO Tomography, Optical Coherence Ophthalmic Class 2 886.1570 2024-10-29
MYC Ophthalmoscope, Laser, Scanning Ophthalmic Class 2 886.1570 2024-10-29
MYC Ophthalmoscope, Laser, Scanning Ophthalmic Class 2 886.1570 2023-11-17
OBO Tomography, Optical Coherence Ophthalmic Class 2 886.1570 2023-11-17

Official Correspondent

Rene Betz

US Agent Details

Ricky Lopez Business: HEIDELBERG ENGINEERING, U.S. Corporate Office Email: Ricky.lopez@heidelbergengineering.com Phone: (508) 5317820

Related Public Records

Same Entity

Heidelberg Engineering GmbH
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0024-2013 Optovue Inc. 2
Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: iVue-100, RTVue-100; The physical Product is manufactured and distributed by Optovue, Inc. Fremont, CA The product is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye scans as an aid in the diagnosis and management of retinal disease.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8043762. Last updated year: 2026. Please use registration number 8043762 when referencing this establishment in official correspondence.
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