Certificates
The philosophy of Biomag® is to produce high quality products that serve their users well for many years. To this end, enormous attention is paid to every detail during the development of our products, both in terms of the utility value and high efficiency of our instruments and in terms of the high quality materials and manufacturing processes used.
Take a look at the certificates for Biomag® magnetic therapy products from prestigious professional authorities, which prove the high quality of Biomag® devices and are recognized for the sale of Biomag® devices not only on the European continent, but also in Asia and America.
System Certificates
The ISO 13485 standard is intended for manufacturers of medical devices and related services and was created due to increased demands on the quality management system for these entities. It helps them provide products and related services of such quality that they can meet customer expectations and comply with the legislative requirements of government authorities.
The issuer of these certificates is: 3EC International
Product Certificates
The EC certificate is an independent verification of the manufacturer’s assessment of the conformity of the product with the requirements of the relevant government regulations. The issuer of the certificate declares that the manufacturer has correctly carried out the conformity assessment process and can issue an EC declaration of conformity.
The manufacturer is obliged to mark the medical device with the CE marking together with the identification number of the notified person responsible for carrying out the tasks provided for in the Medical Devices Act.
The issuer 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 regulations. The certificate is a prerequisite for placing the product on the market. The EC Declaration of Conformity is issued by the manufacturer on the basis of an assessment of the product in question against the requirements of a specific government regulation.
The CB system or IECEE-CB system is the world’s most widely used certification system for electrical products. This is an agreement for the recognition of test results according to IEC international standards for electrical safety of electrical products.
The assessor of these certificates is the Electrotechnical Testing Institute(CB system) and 3EC International(EC Declaration of Conformity).
CB test Certificate – Biomag Lumina
Lumina – 3D-e – EU PROHLÁŠENÍ O SHODĚ
Lumina – 3D-e – EU-KONFORMITÄTSERKLÄRUNG
Lumina – 3D-e – EU DECLARATION OF CONFORMITY
Lumina – 3D-e – DECLARACIÓN UE DE CONFORMIDAD
Lumina – 3D-e – DÉCLARATION DE CONFORMITÉ UE
Lumina – 3D-e – EU IZJAVA O SUKLADNOSTI
Lumina – 3D-e – EU-MEGFELELŐSÉGI NYILATKOZAT
Lumina – 3D-e – DICHIARAZIONE DI CONFORMITÀ UE
Lumina – 3D-e – DEKLARACJA ZGODNOŚCI UE
Lumina – 3D-e – DECLARAÇÃO UE DE CONFORMIDADE
Lumina – 3D-e – DECLARAȚIA DE CONFORMITATE UE
Lumina – 3D-e – ЕС СЕРТИФИКАТ СООТВЕТСТВИЯ
Lumina – 3D-e – EÚ VYHLÁSENIE O ZHODE
Lumina – 3D-e – IZJAVA EU O SKLADNOSTI
Lumina – 3D-e – ДЕКЛАРАЦІЯ ВІДПОВІДНІСТЬ CЄ
Lumina 3D-e – EC tuyên bố về sự phù hợp
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 regulations. The certificate is a prerequisite for placing the product on the market. The EC Declaration of Conformity is issued by the manufacturer on the basis of an assessment of the product in question against the requirements of a specific government regulation.
The certificate issued by the Electrotechnical Testing Institute confirms that it has been issued on the basis of meeting the requirements of the certification scheme and declares that the Biomag® device complies with the requirements of the applicable standards for the safety of medical devices.
The assessor of these certificates is the Electrotechnical Testing Institute(CB system) and 3EC International(EC Declaration of Conformity).
CB test Certificate – Biomag Lumio
Lumio 3D-e – EU PROHLÁŠENÍ O SHODĚ
Lumio 3D-e – EU-KONFORMITÄTSERKLÄRUNG
Lumio 3D-e – EU DECLARATION OF CONFORMITY
Lumio 3D-e – EC tuyên bố về sự phù hợp
Lumio 3D-e – DÉCLARATION DE CONFORMITÉ UE
Lumio 3D-e – EU IZJAVA O SUKLADNOSTI
Lumio 3D-e – EU-MEGFELELŐSÉGI NYILATKOZAT
Lumio 3D-e – DECLARACIÓN UE DE CONFORMIDAD
Lumio 3D-e – DEKLARACJA ZGODNOŚCI UE
Lumio 3D-e – DECLARAÇÃO UE DE CONFORMIDADE
Lumio 3D-e – DECLARAȚIA DE CONFORMITATE UE
Lumio 3D-e – DICHIARAZIONE DI CONFORMITÀ UE
Lumio 3D-e – EÚ VYHLÁSENIE O ZHODE
Lumio 3D-e – IZJAVA EU O SKLADNOSTI
Lumio 3D-e – ДЕКЛАРАЦІЯ ВІДПОВІДНІСТЬ CЄ
Lumio 3D-e – ЕС СЕРТИФИКАТ СООТВЕТСТВИЯ
Biomag® LightFit Duo
The certificate issued by the Electrotechnical Testing Institute confirms that it has been issued on the basis of meeting the requirements of the certification scheme and declares that the Biomag® device complies with the requirements of the applicable standards for the safety of medical devices.
The assessor of the certificate is the Electrotechnical Testing Institute(Certificate) and 3EC International(EC Declaration of Conformity).
Veterinary certificates
The certificate of free sale proves that the veterinary technical product Biomag® Lumina VET can be manufactured and put into circulation for veterinary purposes without restrictions. This certificate allows sales to the European Union and other countries.
The assessor of the certificate is: Institute for State Control of Veterinary Biopreparations and Medicines.
Karel Hrnčíř - Biomag® - company documents
In the extract from the Commercial Register, the business name Karel Hrnčíř – Biomag® 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.
The extract from the trade register proves the ownership of the business firm Karel Hrnčíř – Biomag® for the trade license for business in the field of activity production of medical devices and in other fields.
The issuer of the extract from the Trade Register is: Trade Licensing Office Hořice.
The certificate of registration proves that Karel Hrnčíř – Biomag® 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.
Petr Hrnčíř - Biomag® - company documents
The extract from the trade register shows the ownership of the trade firm Petr Hrnčíř for the business license for business in the field of activity of production of medical devices, mediation of trade and services and in other fields listed in the extract.
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.
Biomag Medical s.r.o. - company documents
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.
Certificate of the Association of Manufacturers and Suppliers of Medical Devices
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.