CHIS, s.r.o.

CHIS, s.r.o. specializes in blood collection and infusion chairs. Their product line includes mechanical and electrical models, such as standalone blood-drawing chairs (e.g., Kardiak) and combined units for both blood collection and infusion (e.g., Plasma PP Plus). Some designs are foldable for space efficiency, like the Odběrové křeslo skládací CHIS 105.

CHIS, s.r.o. is based in the Czech Republic, which means its devices comply with EU medical device regulations. Since they are classified as Class I, they undergo basic conformity assessment procedures under EU directives, ensuring they meet essential safety and performance requirements for their intended use.

Yes, CHIS, s.r.o.’s devices are listed in the EUDAMED database, which is the European Union’s transparency database for medical devices. This listing confirms their registration under EU regulations, allowing healthcare providers and authorities to verify their compliance and traceability.

CHIS, s.r.o.’s devices fall under Class I classification in the EU. This classification applies to low-risk medical devices like blood-drawing and infusion chairs, which pose minimal risk to patients when used as intended. Class I devices typically require basic conformity assessment, such as self-certification by the manufacturer, to demonstrate compliance with EU safety and performance standards.

The inclusion of both mechanical and electrical blood collection and infusion chairs caters to different clinical needs. Mechanical models (e.g., Kardiak) may be preferred for simplicity or in settings where electrical power is unreliable, while electrical models (e.g., Plasma PP Plus) offer programmable features, automated functions, or enhanced precision for complex procedures. The foldable designs further provide flexibility for space-constrained environments.