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Singapore HSA registration DE0506378

Bonraybio LensHooke X1 PRO Semen Quality Analyzer

Singapore flagSingapore·CLASS B IVD·Bonraybio Co., LTD.·Registered November 16, 2021
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Obstetrics & Gynaecology
Registration information
Registration Number
DE0506378
Registration Date
November 16, 2021
Retention Due Date
November 15, 2025
Product description
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.
Product Owner
Name
Bonraybio Co., LTD.
Short Name
Bonraybio Co., LTD.
Address
4F., No.118, Gongye 9th Rd., Dali Dist., Taichung City 41280, TAIWAN
Registrant
Name
LABGISTICS ASIA PTE LTD
Address
76 PIONEER ROAD, MAPLETREE PIONEER LOGISTICS HUB, #03-05, SINGAPORE 639577
Importer
Name
LABGISTICS ASIA PTE LTD
Address
76 PIONEER ROAD, MAPLETREE PIONEER LOGISTICS HUB, #03-05, SINGAPORE 639577
Model information
Model Name(s)
Liquefaction Test Cup Liquefaction Enzyme LensHooke Semen Test Cassette LensHooke X QC Beads (For Semen) LensHooke X QC Video (For Semen) LensHooke X1 PRO Semen Quality Analyzer LensHooke Semen Test Cassette LensHooke X QC Reticle (For Semen)
Model Identifier(s)
98-0CK0003 98-0CK1000 98-0CS0005 98-0QX0002 98-0QXB003 98-0X1000B 98-1CS1001 98-1QXA004
About this record

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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B IVD