Terms of Use

Website: www.clouz.one

Last updated: September 27, 2026

1. Scope and operator

1.1       These Terms of Use (“Terms”) govern access to and use of the website www.clouz.one, including all subpages, content and downloadable documents (the “Website”). The Website is operated by Clouz GmbH, Schinkestr. 9, 12047 Berlin, Germany, registered in the commercial register of the Local Court (Amtsgericht) Charlottenburg under HRB 211973 (“Clouz”, “we”, “us” or “our”). Further information about Clouz is available in our Legal Notice (Impressum).

1.2       By accessing or using the Website, you agree to these Terms. If you do not agree to these Terms, please do not use the Website.

1.3       These Terms apply only to the use of the Website. The supply of products, including samples, is governed exclusively by separate agreements or terms that we will make available to you where relevant.

1.4       Information on how we process personal data in connection with the Website, including the contact form, is set out in our Privacy Policy.

2. Purpose of the Website and intended audience

2.1       The Website provides general information about Clouz and about OneKnot, a medical device bearing the CE marking in accordance with Regulation (EU) 2017/745 on medical devices (“MDR”).

2.2       OneKnot is intended exclusively for use by qualified healthcare professionals trained in surgical techniques, in accordance with its instructions for use (“IFU”). The product and technical information on the Website is directed primarily at healthcare professionals and healthcare institutions (together, “Healthcare Professionals”). Members of the public may access the Website for general information about Clouz. The Website is not intended to advertise OneKnot to patients or to the general public.

2.3       OneKnot may be placed on the market only in countries where the applicable regulatory requirements are met, currently the member states of the European Economic Area, Switzerland, Turkey, Northern Ireland, the United Kingdom, to the extent registered. OneKnot may not be approved, cleared or available in other countries, including the United States of America. Nothing on the Website constitutes an offer, solicitation or promotion of OneKnot in any country where it is not authorised for sale.

2.4       Information on the Website is general in nature and reflects the status at the time of publication. Product specifications, configurations and availability may change. Content on the Website does not constitute a binding offer to conclude a contract.

3. No medical advice

3.1       The content of the Website does not constitute medical advice, diagnosis or a treatment recommendation and does not replace the professional judgement of a qualified Healthcare Professional. The decision whether to use OneKnot, and the choice of surgical technique, is the sole responsibility of the treating surgeon, taking into account the individual patient.

3.2       If you are a patient or a member of the public, please consult your doctor about any questions relating to your health or a surgical procedure. Do not disregard professional medical advice, or delay seeking it, because of anything you have read on the Website.

3.3       The content of the Website does not replace the IFU. Before using OneKnot, always read and follow the applicable IFU, including its indications, contraindications, warnings and precautions.

4. Instructions for use and regulatory documents

4.1       We provide the IFU and certain regulatory documents on the Website for download, such as the MDR EU certificates and the summary of safety and clinical performance, where applicable (together, “Regulatory Documents”).

4.2       Regulatory Documents are provided for information purposes. The authoritative IFU is the version applicable to the specific product concerned, as identified by the reference number, lot number and IFU revision or date on the product label. Please make sure that you are using the IFU version that applies to your product. If in doubt, contact us using the details in section 16.

4.3       You may download, save and print Regulatory Documents for your own professional purposes, including clinical evaluation, internal procurement, quality and regulatory purposes and staff training. You may not alter Regulatory Documents or remove any copyright, trademark or other notices from them.

5. Contact form and sample requests

5.1       You may use the contact form on the Website to send us enquiries and to request a OneKnot sample. Sample requests are intended solely for Healthcare Professionals acting in a professional capacity in the European Economic Area. Please provide accurate and complete professional contact details. Please do not submit any patient data or other health data through the contact form.

5.2       Submitting a sample request does not create a contract or any entitlement to receive a sample. We decide at our sole discretion whether to provide samples, to whom and in what quantity. We may verify the professional status of the requesting person and may decline requests without giving reasons.

5.3       Samples are provided free of charge, in quantities appropriate for evaluation, and without any obligation to purchase. Samples are not provided in return for, or as an inducement to, any purchase, use, recommendation or prescription of our products. Samples may not be sold, passed on to third parties in return for payment, or invoiced to patients or payers.

5.4       Samples must be stored, handled and used strictly in accordance with the IFU and the product labelling.

5.5       Any terms accompanying a sample, or agreed separately in writing, take precedence over this section 5.

6. Reporting incidents and complaints

6.1       If you become aware of a suspected serious incident, malfunction or complaint relating to OneKnot, please notify us without delay at vigilance@clouz.one. Please do not use the general contact form for urgent safety matters.

6.2       Healthcare Professionals may also report suspected serious incidents directly to the competent authority of their country; in Germany, this is the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM).

7. Permitted use

7.1       You may use the Website only for lawful purposes and in accordance with these Terms. In particular, you must not:

•     interfere with, or attempt to interfere with, the security, integrity or availability of the Website, or attempt to gain unauthorised access to it or to any password-protected areas;

•     use automated tools to access, copy or extract content from the Website, except for standard search-engine indexing;

•     submit false information, content belonging to third parties without authorisation, or unlawful, abusive or harmful content through the contact form; or

•     use content from the Website in a misleading way, in particular in connection with medical or promotional claims.

7.2       We reserve all rights to use the content of the Website for text and data mining within the meaning of section 44b of the German Copyright Act (UrhG) and Article 4 of Directive (EU) 2019/790. This reservation is also expressed in machine-readable form.

7.3       If we provide you with access credentials for protected areas of the Website, you must keep them confidential and must not share them with third parties.

8. Intellectual property

8.1       The Website and its content, including text, images, graphics, videos, product illustrations, Documents, the layout and the software, are protected by copyright, trademark and other intellectual property rights and belong to Clouz or its licensors.

8.2       “Clouz”, “OneKnot” and the associated logos are registered trademarks of Clouz GmbH. Other trademarks mentioned on the Website, such as MANI®, are the property of their respective owners.

8.3       OneKnot and its knotting technology are protected by international patents. Nothing on the Website grants you any licence or right to any patent, trademark, copyright or other intellectual property right of Clouz or of any third party, except for the right to view the Website and the rights expressly granted in section 4.4.

9. Links

9.1       The Website currently does not contain links to third-party websites or embedded third-party content. If we add links to third-party websites, we have no control over their content, which is the sole responsibility of their operators. At the time of linking, we check linked pages for obvious legal violations. If we become aware of any violation, we will remove the link without delay.

9.2       You may link to the home page of the Website provided that the link is not misleading and does not suggest any endorsement by or association with Clouz that does not exist. Displaying the Website within a frame of another website requires our prior written consent.

10. Availability and changes to the Website

There is no entitlement to the Website being available. We may change, restrict, suspend or discontinue the Website or any part of it at any time, in particular for maintenance, security or regulatory reasons.

11. Liability

11.1     We are liable without limitation for damage caused intentionally or by gross negligence, for damage resulting from injury to life, body or health, for damage covered by the German Product Liability Act (Produkthaftungsgesetz), in cases of fraudulent concealment of a defect, and where we have given a guarantee.

11.2     In cases of slight negligence, we are liable only for breach of a material obligation (Kardinalpflicht), meaning an obligation whose fulfilment is essential for the proper use of the Website and on whose fulfilment you may regularly rely. In such cases, our liability is limited to the damage that was foreseeable and typical at the time the obligation arose.

11.3     Otherwise, our liability is excluded.

11.4     We take reasonable care to ensure that the content of the Website is accurate and up to date. Subject to sections 11.1 to 11.3, we do not accept any liability for the completeness, accuracy or currency of the general information provided on the Website free of charge.

11.5     The above limitations of liability also apply to the personal liability of our directors, employees, representatives and agents.

12. Changes to these Terms

We may amend these Terms at any time with effect for the future. The version published on the Website at the time you use it applies. The date at the top of these Terms shows when they were last updated.

13. Governing law and place of jurisdiction

13.1     These Terms are governed by the laws of the Federal Republic of Germany, excluding the United Nations Convention on Contracts for the International Sale of Goods (CISG). If you are a consumer, this choice of law does not deprive you of the protection afforded by mandatory provisions of the law of the country in which you are habitually resident.

13.2     If you are a merchant (Kaufmann) within the meaning of the German Commercial Code, a legal entity under public law or a special fund under public law, the exclusive place of jurisdiction for all disputes arising from or in connection with these Terms is Berlin, Germany. We may also bring proceedings at your general place of jurisdiction.

14. Consumer dispute resolution

We are neither willing nor obliged to participate in dispute resolution proceedings before a consumer arbitration board (Verbraucherschlichtungsstelle).

15. Language and severability

15.1     These Terms are available in English and German. In the event of any discrepancy between the two versions, the English version prevails.

15.2     If any provision of these Terms is or becomes invalid or unenforceable, the validity of the remaining provisions is not affected. In place of the invalid or unenforceable provision, the statutory provisions apply.

16. Contact

Clouz GmbH, Schinkestr. 9, 12047 Berlin, Germany

Email: info@clouz.one