ULTRA-VIOL Pietras Purgał Wójcik Spółka Jawna

ULTRA-VIOL Pietras Purgał Wójcik Spółka Jawna specializes in medical imaging equipment. Their product range includes negatoscopes—devices used for viewing X-ray films in radiology and mammography settings—such as wall-mounted, built-in LED, high-frequency, and adjustable-luminance models. They also produce digital inspection stations (e.g., the DiCO series) designed for reviewing both digital and analog X-ray images. These devices are primarily intended for diagnostic environments where precise image analysis is critical.

The company is headquartered in Poland, where it develops and manufactures its medical imaging devices. Its location aligns with EU regulatory frameworks, ensuring compliance with relevant standards for medical devices.

All of ULTRA-VIOL’s medical devices are listed in the eudamed registry, which is the official EU database for medical devices. This registry tracks devices that comply with EU Medical Device Regulations (MDR) or previous directives, ensuring transparency and traceability for healthcare professionals and authorities.

ULTRA-VIOL’s devices fall into EU Class I and Class IIa classifications. Class I devices are generally low-risk (e.g., simple negatoscopes), while Class IIa devices involve moderate risk (e.g., high-frequency or adjustable-luminance negatoscopes) and require additional conformity assessments. Classification determines the regulatory pathway and documentation requirements for each product.