Bonraybio Co L T D

FDA Filings

This page includes the latest FDA filings for Bonraybio Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3014053517
• FEI Number: 3014053517
• Name: BONRAYBIO CO., LTD.
• Owner & Operator: Bonraybio Co., LTD.
• Contact Address: 4F., No. 118, Gongye 9th Rd., Dali Dist. ; Taichung TW-TXG Taichung - Municipality 41280 TW
• US Agent:
  • Feng-Yu Lee
  • Dynamic Biotech, Inc. dba IVDD Regulatory Consultant
  • 949 2180929
  • 949 2180928
  • fengyulee@ivddreg.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 4F., No. 118, Gongye 9th Rd., Dali Dist. ; Taichung Taichung - Municipality, 41280 TW
• Establishment Type:
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 04719874740702 BONRAYBIO CO., LTD.	LensHooke Semen Quality Analyzer	2022-09-16
GUDID 14719874741591 BONRAYBIO CO., LTD.	LensHooke Sperm DNA fragmentation test kit (SCD assay)	2021-11-26
GUDID 04719874741570 BONRAYBIO CO., LTD.	LensHooke Semen Quality Analyzer	2021-09-03
GUDID 54719874741155 BONRAYBIO CO., LTD.	LensHooke semen Test Cassette	2021-07-19
GUDID 54719874741148 BONRAYBIO CO., LTD.	LensHooke semen Test Cassette	2021-07-19
GUDID 54719874740769 BONRAYBIO CO., LTD.	LensHooke semen Test Cassette	2021-07-19
GUDID 54719874740714 BONRAYBIO CO., LTD.	LensHooke semen Test Cassette	2021-07-19
GUDID 44719874741158 BONRAYBIO CO., LTD.	LensHooke semen Test Cassette	2021-07-19
GUDID 44719874741141 BONRAYBIO CO., LTD.	LensHooke semen Test Cassette	2021-07-19
GUDID 44719874740779 BONRAYBIO CO., LTD.	C-KUP Liquefaction Test Cup	2021-07-19
GUDID 44719874740762 BONRAYBIO CO., LTD.	LensHooke semen Test Cassette	2021-07-19
GUDID 44719874740724 BONRAYBIO CO., LTD.	C-KUP Liquefaction Test Cup	2021-07-19
GUDID 44719874740717 BONRAYBIO CO., LTD.	LensHooke semen Test Cassette	2021-07-19
GUDID 14719874740723 BONRAYBIO CO., LTD.	C-KUP Liquefaction Test Cup	2021-01-22
GUDID 14719874741157 BONRAYBIO CO., LTD.	LensHooke Semen Test Cassette	2021-01-21
GUDID 14719874741140 BONRAYBIO CO., LTD.	LensHooke Semen Test Cassette	2021-01-21
GUDID 04719874741099 BONRAYBIO CO., LTD.	LensHooke X QC Video (For Semen) X QC Video	2021-01-01
GUDID 04719874741082 BONRAYBIO CO., LTD.	LensHooke X QC Video (For Semen) X QC Video	2021-01-01
GUDID 04719874741051 BONRAYBIO CO., LTD.	LensHooke X QC Video (For Semen) X QC Video	2021-01-01
GUDID 04719874741044 BONRAYBIO CO., LTD.	LensHooke X QC Video (For Semen) X QC Video	2021-01-01
GUDID 04719874741037 BONRAYBIO CO., LTD.	LensHooke X QC Video (For Semen) X QC Video	2021-01-01
PMN K202089 Bonraybio Co., Ltd.	LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer	2020-10-28
GUDID 04719874740900 BONRAYBIO CO., LTD.	LensHooke X QC Reticle (For Semen) X QC Reticle	2020-03-24
GUDID 04719874740894 BONRAYBIO CO., LTD.	LensHooke X QC Reticle (For Semen) X QC Reticle	2020-03-24
GUDID 04719874740887 BONRAYBIO CO., LTD.	LensHooke X QC Reticle (For Semen) X QC Reticle	2020-03-24
GUDID 04719874740870 BONRAYBIO CO., LTD.	LensHooke X QC Reticle (For Semen) X QC Reticle	2020-03-24
GUDID 04719874740863 BONRAYBIO CO., LTD.	LensHooke X QC Reticle (For Semen) X QC Reticle	2020-03-24
GUDID 04719874740856 BONRAYBIO CO., LTD.	LensHooke X QC Reticle (For Semen) X QC Reticle	2020-03-24
GUDID 04719874740849 BONRAYBIO CO., LTD.	LensHooke X QC Reticle (For Semen) X QC Reticle	2020-03-24
GUDID 04719874740832 BONRAYBIO CO., LTD.	LensHooke X QC Reticle (For Semen) X QC Reticle	2020-03-24
PMN K180343 | POV BONRAYBIO CO., LTD.	LensHooke X1 Semen Quality Analyzer	2018-11-18
PMN K180343 | POV BONRAYBIO CO., LTD.	LensHooke X1 PRO Semen Quality Analyzer	2018-11-18
PMN K180343 | POV BONRAYBIO CO., LTD.	LensHooke Semen Test Cassette	2018-11-18
PMN K180343 | GKZ BONRAYBIO CO., LTD.	LensHooke X1 Semen Quality Analyzer	2018-11-18
PMN K180343 | GKZ BONRAYBIO CO., LTD.	LensHooke X1 PRO Semen Quality Analyzer	2018-11-18
PMN K180343 | GKZ BONRAYBIO CO., LTD.	LensHooke Semen Test Cassette	2018-11-18
NRF BONRAYBIO CO., LTD.	LensHooke X QC Reticle (For Semen)	2018-11-18
NRF BONRAYBIO CO., LTD.	LensHooke X QC Beads (For Semen)	2018-11-18
PMN K180343 Bonraybio Co., Ltd.	LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer	2018-11-16
NNI BONRAYBIO CO., LTD.	C-KUP Liquefaction Test Cup	2017-10-26