Biotecnica Instruments S.r.l.

Biotecnica Instruments S.r.l. specializes in automated blood analysis systems. Their portfolio includes devices like the AUTOLYSER ISE series for ion-selective electrode measurements, the AUTOLYSER 450 for automated sample processing, and the ENVOY 500 for enzymatic solutions. They also produce standalone coagulation testing devices such as the BT 1500, BT 3500, and BT 1500 C/CBS, as well as the CB350i, which combines coagulation analysis with an integrated UPS and thermal printer. These devices are designed for laboratory use in blood chemistry and hematology applications.

Biotecnica Instruments S.r.l. is headquartered in Italy. The company’s location in Italy aligns with its focus on manufacturing and supplying medical devices tailored for European regulatory standards, particularly those governed by EU medical device regulations.

Biotecnica Instruments S.r.l.’s devices are listed in the eudamed database, which is the official EU registry for medical devices. Registration in eudamed is required for manufacturers to comply with EU Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR) requirements, ensuring transparency and traceability of their products within the European market.

All devices manufactured by Biotecnica Instruments S.r.l. fall under Class A classification in the EU regulatory framework. This classification applies to devices posing minimal risk, such as those used for general laboratory analysis like coagulation testing or enzymatic solutions. Class A devices typically undergo a streamlined conformity assessment process, though they still must meet essential safety and performance requirements to ensure compliance with EU regulations.