Bonraybio LensHooke X1 PRO Semen Quality Analyzer - HSA Registration DE0506378
Access comprehensive regulatory information for Bonraybio LensHooke X1 PRO Semen Quality Analyzer in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0506378 and owned by Bonraybio Co., LTD.. The device was registered on November 16, 2021.
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 LensHooke X1 PRO Semen Quality Analyzer used with LensHooke Semen Test Cassette is an optical device for human semen analysis which provides direct and calculated quantitative measurements for: (1) Sperm concentration (106 per ml) (2) Total motility (PR+NP, %) • Progressive motility (%) • Non-Progressive motility (%) • Immotility (%) • Other parameters from CASA assessment (MSC, PMSC, VAP, VSL, VCL, LIN, STR, WOB, ALH, and BCF) (3) Sperm morphology (normal forms, %) (4) pH value The LensHooke X1 PRO Semen Quality Analyzer does not provide a comprehensive evaluation of a male’s fertility status and is intended for in vitro diagnostic use. Only for professional use.