Belpro Medical Inc.

Belpro Medical Inc. specializes in reusable biopsy syringe holders. These devices are engineered to provide stable and precise support for biopsy needles during tissue sample collection in clinical procedures. The design helps improve accuracy and ease of use in medical settings.

Belpro Medical Inc. is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations. The FDA’s Unique Device Identifier (UDI) database includes its products, which are classified under FDA Class II—a designation for devices posing moderate risk that require special controls to ensure safety and effectiveness.

Belpro Medical Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the U.S., ensuring transparency and traceability for healthcare providers and regulators.

Belpro Medical Inc.’s devices fall under FDA Class II classification. This classification is assigned to medical devices that are not low-risk (like Class I) but do not require the stringent premarket approval process of Class III. Class II devices typically involve special controls—such as performance standards, post-market surveillance, or labeling requirements—to mitigate risks while facilitating patient access.