ThermaSolutions Hurrichem Device Kit - HSA Registration DE0510174
Access comprehensive regulatory information for ThermaSolutions Hurrichem Device Kit in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0510174 and owned by ThermaSolutions LLC. The device was registered on December 20, 2024.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
The HurriChem Device Kit is intended for the minimally invasive administration of aerosolized liquids. It is intended for laparoscopic nebulization of high- pressure drugs for pressurized laparoscopic aerosolization treatment. The target subject population is composed of patients with confirmed peritoneal carcinomatosis, with tumor progression or reoccurrence after intravenous chemotherapy, and the ability to tolerate general anesthesia and minimally invasive surgery. PIPAC is used in selected patient with peritoneal metastasis who have no indication for cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemoperfusion (HIPEC). The use of this device is restricted to the treatment of peritoneal carcinomatosis originating from ovarian, gastric, colorectal, and peritoneal mesothelioma cancers, and is intended solely for use with Oxaliplatin, Cisplatin, and Doxorubicin.