Certificates

Due to the ever-increasing demands on the quality management of manufacturers and suppliers, the ISO 13485 standard provides the basis for the certification of quality management systems in companies that manufacture or distribute medical devices or participate in their production as part of the supply chain.

The issuer of these certificates is: 3EC International a.s.

The EC certificate of the quality management system documents an independent assessment of the conformity of manufactured medical devices according to Regulation (EU) 2017/45 on medical devices (MDR), which the manufacturer ensures through a notified body.

The issuer of these certificates is: 3EC Internetional a.s. .

The most widespread worldwide certification system in the field of electrotechnical products is the IECEE-CB system, or CB system. This is an agreement on the recognition of test results according to international IEC standards for the electrical safety of electrotechnical products.

The certificate issued by the Electrotechnical Testing Institute confirms that it was issued on the basis of meeting the requirements of the certification scheme and declares that the BIOMAG® medical device complies with the requirements of the applicable standards for the safety of medical devices.

The issuer of these certificates is: Electrotechnical Testing Institute, s.p.

The declaration of conformity is a document by which the manufacturer confirms that the conformity of the product with the requirements of the applicable legislation was correctly assessed.

The assessor of these certificates is: Assessor: 3EC International a.s.

Biomag® Lumina 3D-e

The certificate proves that the veterinary technical device BIOMAG® Lumina VET can be produced and placed on the market for veterinary purposes.

The issuer of the certificate is: Institute for State Control of Veterinary Biopreparations and Medicines.

The extract from the trade register proves that Petr Hrnčíř owns the trade licence for business in the field of producing medical devices and mediation of trade and services and in other fields listed in the listing.
The issuer of the extract from the Trade Register is: Trade Licensing Office Hořice.

The registration decision proves that Petr Hrnčíř is a payer of value added tax.
The issuer of the Certificate of Registration of Value Added Tax Payer is the Financial Office in Hořice.

In the extract from the Commercial Register, Biomag Medical s.r.o. provides basic identifying information about the company.
The accuracy of the extract from the Commercial Register is confirmed by the Regional Court in Hradec Králové.

Biomag Medical s.r.o. is registered in the Register of Economic Operators (EORI register) and has been assigned a unique identifier (EORI number – Economic Operators Registration and Identification number). The EORI number serves as a unique identifier when communicating with customs authorities.
The issuer of the decision on the allocation of the economic operator identifier (EORI number) is: Customs Office for the Hradec Králové Region.

The registration decision proves that Biomag Medical s.r.o. is a payer of value added tax.
The issuer of the Decision on registration of the value added tax payer is the Financial Office for the Hradec Králové Region, Territorial Office in Jičín.

Biomag® is a member of the Association of Medical Device Manufacturers and Suppliers. All companies that are members of the Association declare the high quality of their products and customer relations.