ReGelTec Inc.

ReGelTec Inc. manufactures medical devices under the HYDRAFIL brand, including a procedure kit, a pressure gauge, and a delivery system. These devices are specifically designed for spinal applications and are intended to support procedures related to degenerative disc disease, such as injection, pressure monitoring, and administration of therapeutic agents.

ReGelTec Inc. is headquartered in the United States. The company’s location is relevant for understanding its regulatory jurisdiction and operational base, particularly when assessing compliance with US and international medical device regulations.

ReGelTec Inc.’s devices are listed in the EU’s eudamed database. This registry is used to track medical devices that comply with European Union regulations, ensuring transparency and traceability for authorized products within the EU market.

ReGelTec Inc.’s devices fall under Class III classification. This classification is the highest risk tier under medical device regulations, requiring rigorous pre-market approval processes and ongoing compliance to ensure safety and efficacy, particularly for devices intended for critical procedures like those related to degenerative disc disease.