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Certificate of conformity
This certificate has been issued according to the voluntary application of the manufacturer. This certificate is valid only for the product(s) in above mentioned. This certificate confirms that the decleration of conformity which is prepared by manufacturer is available. It’s manufacturer’s sole responsibility to meet all the neccessary conformity assessment activities according to European Medical Device Regulation 2017/745 and related standards or the mentioned product(s) before placing them on the market. It is the manucturer’s responsibility to comply a full technical file according to Annex VII of 2017/745 and the manufacturer is the responsible to take all necessary actions before affixing CE mark on the product(s)
ISO 9001
INSPECT assessed and approved that related firm meets the requirements of the designated standard at related scope
ISO 13485
INSPECT assessed and approved that related firm meets the requirements of the designated standard at related scope
Declaration of conformity
The statement is based on a single evaluation of one sample of above mentioned products. The manufacturer should ensure that all products in series production are in conformity with the product sample detailed in this report. Technical reports and documentation are at the manufacturer disposal. Responsibility for product safety and compliance with the requirements of the Directives: European Parliament and of the Council of the European Union Medical Device Regulation 2017/745 and harmonized Standards are issued under the sole responsibility of the manufacturer. The declaration is valid until the introduction of modifications of the technical parameters of the products and production process. Other relevant Directives have to be observed.
| Business Type | Manufacturer, Distributor/Wholesaler |
| Company | UkrHoreca |
| Main Products | Eco paper sraw, medical scope |
| Website | ukrhoreca.com.ua |
| Established Year | 2012 |
| City / State | Bakhmut , Ukraine |
| Country | Ukraine |
| Address | Mira street , 89 |
| Location | Bakhmut |
| Factory Size | 1740 |
| Total QC Staff | 3 |
| Total RND Staff | 30 |
| Number of Production Lines | 3 |
| Annual output | |
| Average Lead Time |
| Total Revenue | |
| Export Percentage | |
| Nearest Port | Odessa merchant sea port |
| Overseas Office |
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