Legal Notice/Imprint

This Legal Notice is provided in accordance with applicable transparency obligations for commercial websites, including § 5 of the German Telemediengesetz (TMG), corresponding provisions of the Austrian E-Commerce Act (ECG) and the Swiss Federal Act against Unfair Competition (UWG), and Articles 5 and 6 of the EU Directive 2000/31/EC on electronic commerce.

Operator of the Website

CuraSource Medical

Trading name of: Jiangsu Kanghua Medical Equipment LLC

United States Headquarters: Seattle, Washington, United States of America

Manufacturing operations: People’s Republic of China

(For the postal address of our Portland office and our Chinese manufacturing facility, please contact us at the email address below; they are provided on request and in the order confirmations we send to business customers.)

Contact

Email: ian.shen@curasourcemedical.com

Phone: +1 (425)-269-0000

Authorized Representative for Service of Process

Ian Shen, in his capacity as the authorized representative of CuraSource Medical, is responsible for receiving formal communications relating to this Site at the email address above.

Person Responsible for Content (V.i.S.d.P. / RStV § 18)

For purposes of § 18 of the German Interstate Treaty on Media (Medienstaats-vertrag) and equivalent provisions in Austria and Switzerland, the person responsible for the editorial content of this Site is:

Ian Shen, CuraSource Medical, Seattle, Washington, United States

Commercial Register and Identification

Jiangsu Kanghua Medical Equipment LLC is organized under the laws of the People’s Republic of China. The unified social credit code, business registration details, and the corresponding details for any U.S. or other registered affiliates are available on request to the contact address above and will be provided to legitimate business counterparties as part of supplier qualification.

Regulatory Information

CuraSource Medical manufactures medical devices. Regulatory information relevant to our products may include:

Quality-management certification to ISO 13485 (Medical devices — Quality management systems);
U.S. FDA establishment registration and applicable 510(k) clearances or other authorizations for products marketed in the United States;
CE-marking under Regulation (EU) 2017/745 on medical devices (MDR), with the involvement of the notified body identified on the relevant Product;
UKCA marking under the U.K. Medical Devices Regulations 2002 (as amended);
NMPA (National Medical Products Administration of the People’s Republic of China) registration for products marketed in China;
Health Canada Medical Device Establishment Licence and applicable Medical Device Licences;
Other applicable national authorizations in the export markets in which the relevant Product is supplied.

The specific certifications, clearances, and registrations applicable to any given Product are stated on the Product’s Documentation or are available on request.

EU Authorized Representative

Where required under Article 11 of Regulation (EU) 2017/745 (MDR), CuraSource Medical appoints an EU Authorized Representative for the relevant Products. The current EU Authorized Representative for a particular Product is identified on the Product label and Instructions for Use. Inquiries may be directed to the email address above.

U.K. Responsible Person

Where required under the U.K. Medical Devices Regulations 2002, CuraSource Medical appoints a U.K. Responsible Person (“UKRP”). The current UKRP for a particular Product is identified on the Product label and Instructions for Use. Inquiries may be directed to the email address above.

Swiss Authorized Representative

Where required under the Swiss Medical Devices Ordinance (MedDO), CuraSource Medical appoints a Swiss Authorized Representative (“CH-REP”). The current CH-REP for a particular Product is identified on the Product label and Instructions for Use.

EU Online Dispute Resolution

The European Commission provides a platform for online dispute resolution (ODR) available at https://ec.europa.eu/consumers/odr. CuraSource Medical does not sell to consumers and is not obligated to participate in consumer ODR procedures, but we provide this reference for completeness.

Liability for Content

As a service provider, CuraSource Medical is responsible for our own content on this Site in accordance with general law. We are not, however, obligated to monitor third-party information transmitted or stored, or to investigate circumstances that indicate illegal activity, where such monitoring would be inconsistent with Articles 12–15 of Directive 2000/31/EC, Articles 4–6 of Regulation (EU) 2022/2065 (the Digital Services Act), or analogous provisions of U.S. or other applicable law. Upon notification of any specific infringement, we will remove the relevant content without undue delay.

Liability for Links

Our Site may contain links to external websites operated by third parties whose content we have no control over. We cannot accept any responsibility for the content of linked sites. Responsibility for the content of any linked site lies exclusively with its operator. If we become aware of any infringement on a linked site, we will remove the link without undue delay.

The content, layout, design, and structure of this Site are protected by copyright, trade-mark, and other intellectual-property laws. Any reproduction, adaptation, distribution, public performance, or other exploitation requires our prior written consent. Permitted uses are described in our Terms and Conditions.

Trademarks

“CuraSource,” “CuraSource Medical,” and our logos are trademarks of CuraSource Medical. All other product, service, and company names mentioned on the Site may be trademarks of their respective owners.

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