Certificates

The philosophy of the Biomag® company is to produce high quality state-of-the-art products, which help users reliably for a long time. For this reason, every detail is highly stressed during the development of our products from the viewpoint of usage value and high efficiency of our devices, or from the viewpoint of the top quality materials used and production processes.

Take a look at our certificates for Biomag® magnetic therapy products issued by prestigious expert authorities, which prove the high quality of Biomag® devices and provide for the sale of Biomag® devices not only in Europe, but in Asia and the Americas, too.

Quality management certificates in the production of medical devices.

Management system certification

The ISO 13 485 standard is intended for manufacturers of medical devices and related services and has been created because of the higher demands on the quality management system for these subjects. It helps them to provide products and related services in quality to be able to meet customer expectations and to meet the legal requirements of government authorities.

The issuer of these certificates is: 3EC International

Product certification

The EC certificate is an independent verification of the conformity assessment of the product with the requirements of the relevant Government Orders, which are carried out by the manufacturer. The EC certificate exporter declares that the manufacturer has correctly performed the conformity assessment process and may issue the EC declaration of conformity.

The producer must ensure that medical devices bear CE marking, followed the identification number of the notified body responsible for the conformity assesment set out in the regulation about medical devices.

The exhibitor of these certificates is: 3EC International

Biomag® Lumina 3D-e

The Declaration of Conformity is a document by which Biomag® proves that it has correctly assessed the conformity of the product with the requirements of the relevant government orders. The certificate is a necessary condition for placing the product on the market. The manufacturer issues the EC Conformity Declaration on the basis of an assessment of the product in question with the requirements of a specific Government Regulation.

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

The examiner of these certificates is: Electrotechnical Testing Institute (CB system) and 3EC International  (Declaration of Conformity)

Biomag® Lumio 3D-e

The Declaration of Conformity is a document by which Biomag® proves that it has correctly assessed the conformity of the product with the requirements of the relevant government orders. The certificate is a necessary condition for placing the product on the market. The manufacturer issues the EC Conformity Declaration on the basis of an assessment of the product in question with the requirements of a specific Government Regulation.

The certificate issued by the Electrotechnical Testing Institute confirms that it was issued on the basis of compliance with the certification scheme requirements and declares that the Biomag® equipment is in compliance with the requirements of the applicable standards for the safety of medical devices.

The examiner of these certificates is: Electrotechnical Testing Institute (CB system) and 3EC International  (Declaration of Conformity)

Biomag® LightFit Duo

Certificate issued by the Electrotechnical Testing Institute confirms that was issued to meet the requirements of the certification scheme and declares that the equipment Biomag® conforms with the requirements of applicable standards for safety of medical devices.

The examiner of the certificate is: Electrotechnical Testing Institute (Certificate) and 3EC International  (Declaration of Conformity)

Veterinary certificates

The Free Sales Certificate proves that the Biomag® Lumina VET veterinary product may be manufactured and unlimited for veterinary purposes. This certificate allows sales to countries of the European Union and other countries.

The examiner of the certificate is: Institute for state control of veterinary bioproducts and pharmaceuticals.

Karel Hrnčíř - Biomag - corporate documents

In the extract from the Commercial Register, Karel Hrnčíř – Biomag® provides necessary identification information about the company. The Regional Court confirms the correctness of the extract from the Commercial Register in Hradec Králové.

An extract from the Trade Register Register proves for the company Karel Hrnčíř – Biomag® ownership of trade license for business activities in the field of production of medical devices and other fields. The publisher of the extract from the Trade Register is: Trade Licensing Office in Hořice.

The registration certificate is certified by Karel Hrnčíř – Biomag® that he is a taxpayer of value-added tax. The issuer of the Registration Certificate of Value Added Tax is: Financial Office in Hořice

Petr Hrnčíř - Biomag - corporate documents

The extract from the Trade Register Register proves for the business firm Petr Hrnčíř the ownership of a trade license for business activities in the field of production of medical devices, mediation of trade and services and in other branches in the statement mentioned above. The publisher of the extract from the Trade Register is: Trade Licensing Office in Hořice.

Petr Hrnčíř documents the decision on registration that he is a taxpayer of value-added tax.
The issuer of the Registration Certificate of Value Added Tax is: Financial Office in Hořice.

Biomag medical s.r.o. - corporate documents

An extract from the Commercial Register is provided by Biomag Medical s.r.o. basic company identification information. The Regional Court confirms the correctness of the extract from the Commercial Register in Hradec Králové.

Biomag Medical s.r.o. is registered with the Economic Operator Register (EORI) and has been assigned a unique identifier (EORI). The EORI number serves as a unique identifier when communicating with customs authorities. The issuer of the decision to assign the identifier of the economic operator (EORI number) is: Customs Authority for the Hradec Králové Region.

By the registration decision, Biomag Medical s.r.o. proves that it is a taxpayer of value-added tax. issuer, The registration decision of the VAT payer, is: Financial Office for the Hradec Králové Region, Territorial Office in Jičín.

Certificate of the Association of Manufacturers and Suppliers of Medical Devices