Imprint

Service Provider

Detalex GmbH
Röntgenstrasse 35
68535 Edingen-Neckarhausen
Germany

Contact

Phone: +49 6203 8399552
Email: info@detalex.de
Web: detalex.de

Managing Director

[Name of Managing Director]

Commercial Register

Registry Court: [Local Court]
Registration Number: HRB [Number]

VAT Identification Number

VAT ID pursuant to § 27a of the German VAT Act (UStG):
DE215014172

Editorial Responsibility

Detalex GmbH
Röntgenstrasse 35
68535 Edingen-Neckarhausen

EU Online Dispute Resolution

The European Commission provides a platform for online dispute resolution (ODR): https://ec.europa.eu/consumers/odr/. Our email address can be found above in this imprint.

We are not willing or obliged to participate in dispute resolution proceedings before a consumer arbitration board.

Medical Device Regulation Disclaimer

Oddy Medicator is a software service for automated classification and cataloging of medical devices. Oddy Medicator is not a medical device itself within the meaning of Regulation (EU) 2017/745 (Medical Device Regulation, MDR) and is not approved or certified as such.

The classification results and catalog codes provided by Oddy Medicator serve exclusively for organizational assignment and management. They do not replace:

• Regulatory classification under MDR Annex VIII
• CE conformity assessment
• Risk classification by a Notified Body
• EUDAMED registration or UDI assignment

Manufacturers and operators of medical devices remain solely responsible for compliance with all applicable regulatory requirements under the MDR and relevant national implementing legislation.

Disclaimer

Liability for Content

As a service provider, we are responsible for our own content on these pages in accordance with general legislation pursuant to § 7 (1) TMG. However, pursuant to §§ 8 to 10 TMG, we are not obligated to monitor transmitted or stored third-party information.

AI-powered classification is provided to the best of our knowledge but without guarantee of completeness or accuracy. Liability for the correctness of automated classifications is excluded.

Disclaimer for external catalog data

Oddy Medicator enriches device information from public sources including the FDA GUDID, FDA 510(k) databases, EUDAMED, and other manufacturer and regulatory registries. After every automated import, plausibility checks are performed (manufacturer domain, model names, categories, production years) to rule out obvious errors.

Despite these checks, no warranty can be given for the accuracy, timeliness, or completeness of data imported from external sources. The information displayed in Medicator must not be used as the sole basis for medical, safety-critical, or regulatory decisions. While we make every effort to keep the data correct, individual entries may be outdated, incomplete, or inaccurate.

Use of the linked external registries (FDA, EUDAMED, etc.) is subject to the respective operators' terms of service. For safety-relevant decisions, cross-checking directly with the source databases or the manufacturer is required.

Liability for Links

Our website contains links to external third-party websites over whose content we have no influence. The respective provider or operator is always responsible for the content of linked pages.

Copyright

The content and works created by the site operators on these pages are subject to German copyright law. Duplication, processing, distribution and any kind of use beyond the limits of copyright law require the written consent of the respective author or creator.