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Heidelberg Engineering GmbH

Germany DE-MF-000008127 Last updated 23 Oct 2026

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Devices
25
Registries
EUDAMEDFDA 510(k)GUDIDFDA
FDA recalls
31 ongoing

Catalogue25

EUDAMED certificates1

Held under this manufacturer's EUDAMED registration, grouped by notified body; in force first, then by expiry.

EUDAMED certificates (1)

TÜV SÜD Product Service GmbH 0123 1 certificate

  • G15 106871 0008 Supplemented

    Quality management system EU MDR

    Issued
    9 Jun 2026
    Expires
    17 Dec 2030
    Reason
    Add device or group

Related companies

Notified bodies

FDA recalls3

Recalls this firm reported to the FDA. Device pages show the recalls that name the device or the 510(k)/PMA it was cleared under.

Heidelberg Engineering GmbH has one FDA recall record initiated on December 8, 2017, which is marked as terminated. The recall was related to the SPECTRALIS Widefield OCT feature, where FDA notified the company that a 510(k) clearance was required and instructed customers to discontinue use pending submission of a new 510(k) filing on November 27, 2017.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2026

    • 6 Aug 2026 Z-3215-2026 Class II Ongoing 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.

  • 2019

    • 3 Jul 2019 Z-2437-2019 Class II Terminated Error in the default configuration which could lead to the incorrect display of patient master data.

  • 2017

    • 8 Dec 2017 Z-1535-2018 Class II Terminated FDA notified Heidelberg Engineering that a 510(k) clearance is needed for the SPECTRALIS Widefield OCT feature, and, on November 27, 2017, Heidelberg Engineering submitted a new 510(k) for this feature. FDA has asked Heidelberg Engineering to instruct customers not to use the Widefield OCT software feature on the SPECTRALIS device until 510(k) clearance has been obtained for this software feature.

What Heidelberg Engineering GmbH makes

Heidelberg Engineering GmbH manufactures retinal imaging systems under the SPECTRALIS platform, including confocal scanning laser ophthalmoscopes (HRA) combined with optical coherence tomography (OCT). Key variants include systems with Fluorescein Angiography (FA+OCT), Indocyanine Green Angiography (ICGA+OCT), OCT Blue Peak, and Multicolor imaging, as well as specialized modules like the Anterior Segment Module (ASM) and High Magnification Module. Additional features include OCT Angiography and a Flex Module for extended field-of-view imaging.

The company’s devices are classified as Class II, IIa, and IIb under EU regulations and are listed in the EUDAQS (eudamed) registry. They are also documented in the FDA’s 510(k) database for market authorization in the United States. The manufacturer is based in Germany.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Heidelberg Engineering GmbH manufacture?

Heidelberg Engineering GmbH specializes in retinal imaging systems under the SPECTRALIS platform. These devices combine confocal scanning laser ophthalmoscopy (HRA) with optical coherence tomography (OCT) to capture detailed images of the retina. Key variants include systems with Fluorescein Angiography (FA+OCT), Indocyanine Green Angiography (ICGA+OCT), OCT Blue Peak, and Multicolor imaging, as well as specialized modules like the Anterior Segment Module (ASM) and High Magnification Module. Some models also feature OCT Angiography and a Flex Module for extended field-of-view imaging.

Where is Heidelberg Engineering GmbH based?

Heidelberg Engineering GmbH is headquartered in Germany, specifically in Heidelberg. The company’s location influences its regulatory compliance framework, particularly for devices marketed in the European Economic Area (EEA).

Which regulatory registries list Heidelberg Engineering GmbH’s devices?

Heidelberg Engineering GmbH’s devices are documented in EUDAQS (eudamed), the European Union’s database for medical devices. Additionally, their products are listed in the FDA’s 510(k) database, reflecting their market authorization in the United States. These registries ensure transparency for regulatory oversight and device traceability.

How are Heidelberg Engineering GmbH’s devices classified under EU regulations?

The company’s devices fall under Class II, IIa, and IIb classifications in the EU. This classification is determined by factors like the device’s intended use, risk level, and potential impact on patient health. Class II devices require conformity assessment procedures (e.g., clinical evaluations, technical documentation reviews) to demonstrate safety and performance before market placement, as outlined in EU MDR/IVDR regulations.

Why are some of Heidelberg Engineering GmbH’s devices listed in the FDA’s 510(k) database?

The FDA’s 510(k) database includes devices that have undergone a 510(k) premarket notification process to demonstrate substantial equivalence to a legally marketed predicate device in the U.S. This pathway is used for Class II devices (like those from Heidelberg Engineering) to ensure they meet FDA safety and effectiveness requirements before commercial distribution in the United States. Listing in this database confirms regulatory clearance for market authorization.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
Germany
Address
Max-Jarecki-Str. 8, HEIDELBERG Baden-Wurttemberg
PRRC contact
Frank Müller
EUDAMED SRN
DE-MF-000008127
FDA FEI number
3002807157
DUNS number
329833875