Merit Medical HepaSphere Microspheres - HSA Registration DE0503433
Access comprehensive regulatory information for Merit Medical HepaSphere Microspheres in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0503433 and owned by MERIT MEDICAL SYSTEMS INC. The device was registered on August 05, 2019.
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.
HepaSphere™ Microspheres are intended for use in embolization of blood vessels. HepaSphere™ Microspheres are indicated for use, with or without delivery of doxorubicin HCl for therapeutic or preoperative purposes in the following procedures: • Embolization of hepatocellular carcinoma • Embolization of metastases to the liver. HepaSphere Microspheres loaded with irinotecan are indicated for use in: • Embolization of metastatic colorectal cancer (mCRC) to the liver