HP BIOPROTESES LTDA

HP Bioproteses Ltda. specializes in external ventricular drainage systems, including separate valve and catheter assemblies for cerebrospinal fluid (CSF) management. They also produce programming devices for programmable ventricular shunts, such as the SPHERA PRO programmable valve with its dedicated programming unit (REG-PRO). These devices are designed to provide controlled drainage in clinical settings where precise CSF regulation is critical.

HP Bioproteses Ltda. is based in Brazil. While its devices are manufactured under Brazilian regulatory requirements, certain products—such as those classified under EU regulations—are listed in the EUDAMED database. This indicates compliance with the European Medical Device Regulation (MDR) or previous directives for devices marketed in the EU.

HP Bioproteses Ltda.’s devices fall into two EU classification categories: Class I for lower-risk products (e.g., some drainage accessories) and Class III for higher-risk devices (e.g., programmable ventricular shunts and their programming units). Class III classification applies due to their direct involvement in life-sustaining or critical functions, requiring stringent regulatory oversight.

Yes, HP Bioproteses Ltda.’s relevant devices are included in the EUDAMED database, which is the official EU registry for medical devices. Listing in EUDAMED confirms that these products have undergone the necessary conformity assessment procedures under EU regulations, such as MDR or previous directives, to be legally marketed in the European Economic Area.

HP Bioproteses Ltda.’s systems include modular components like separate valve and catheter assemblies, which allow for customization based on clinical needs. Additionally, their programmable ventricular shunts (e.g., SPHERA PRO) are paired with dedicated programming devices (like REG-PRO), enabling adjustable drainage settings. This modular and programmable approach differentiates their offerings, particularly for complex CSF management cases requiring dynamic control.