CE Mark Certification

The Ongo Vision microscope, manufactured by Ongo Vettech Kft., has been certified with the CE mark, indicating its compliance with the relevant European Union (EU) directives and standards. This article provides an overview of the CE certification for the Ongo Vision device and the implications for users.

EU Declaration of Conformity

Ongo Vettech Kft. has issued an EU Declaration of Conformity (Declaration number: ONGO-EU-001) under their sole responsibility. This declaration confirms that the Ongo Vision microscope complies with the following EU regulations and directives:

Restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS) Directive 2011/65/EU and 2014/35/EU (LVD)
Electromagnetic Compatibility (EMC) Directive 2014/30/EU

Compliance with EU Standards

The Ongo Vision microscope has undergone rigorous testing to ensure compliance with the following EU standards:

EMC compliance test according to standard MSZ EN 55014-1:2017
EMC compliance test according to standard MSZ EN 55014-2:2015
EMC compliance test according to standard MSZ EN 61326-1:2021

These standards verify that the device meets the necessary requirements for electromagnetic compatibility, ensuring that it does not cause harmful interference to other electronic devices and can function properly in its intended electromagnetic environment.

Significance of CE Marking

The CE mark on the Ongo Vision microscope signifies that the device has been assessed and deemed to meet the high safety, health, and environmental protection requirements of the European Union. This certification is mandatory for products sold within the European Economic Area (EEA).

For users, the CE marking provides assurance that the Ongo Vision device:

Is safe to use and does not pose any health risks when used as intended
Has been designed and manufactured to meet the relevant EU standards and directives
Can be freely marketed and sold within the EEA without additional testing or certification

Manufacturer Responsibility

As the manufacturer of the Ongo Vision microscope, Ongo Vettech Kft. is solely responsible for ensuring that the device complies with the applicable EU directives and standards. The company has signed the EU Declaration of Conformity on behalf of and in representation of Ongo Vettech Kft., located at:

Ongo Vettech Kft 2462 Martonvásár, Szent Laszlo ut 3. Tax number: HU27997255

Conclusion

The CE mark certification for the Ongo Vision microscope demonstrates Ongo Vettech Kft.'s commitment to providing a safe, reliable, and compliant device for semen analysis. Users can trust that the Ongo Vision microscope meets the stringent requirements set by the European Union, ensuring a high-quality product that can be used with confidence across the EEA. You can download it from here.

For more information on the Ongo Vision microscope's technical specifications and compliance with other international standards, please refer to the Technical Specifications section of our knowledge base.