Taiwan FDA registration 2891c47ae498b1f11af78a64bd6da201

LensHooke Sperm DNA fragmentation test kit (SCD assay) (Non-Sterile)

TW: 萊特兒精子DNA碎片檢測試劑套組(精子染色質擴散法) (未滅菌)
Taiwan flagTaiwan·Risk Class 1·MD·BONRAYBIO CO., LTD.·Registered Oct 01, 2021 – Oct 31, 2026Active
Registration details
Analysis ID
2891c47ae498b1f11af78a64bd6da201
License Form
Ministry of Health Medical Device Manufacturing Registration No. 009230
Company information
Manufacturer Country
Taiwan, Province of China
Authorized Representative
BONRAYBIO CO., LTD.
Product details
Intended Use
Limited to the first grade identification range of medical equipment classification and grading management methods dyes and chemical solution dyes (B.1850).
Product Type (Level 1)
B Hematology and pathology devices
Product Type (Level 2)
B1850 Dyes and chemical solution dyes
Import Information
Produced in Taiwan, China
Dates and status
Registration Date
Oct 01, 2021
Expiry Date
Oct 31, 2026
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About this record

Access comprehensive regulatory information for LensHooke Sperm DNA fragmentation test kit (SCD assay) (Non-Sterile) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 2891c47ae498b1f11af78a64bd6da201 and manufactured by BONRAYBIO CO., LTD.. The authorized representative in Taiwan is BONRAYBIO CO., LTD..

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including BONRAYBIO CO., LTD., and 1 recent registrations in the same category. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.

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