FDA.report

BONRAYBIO CO., LTD.

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30140535173014053517BONRAYBIO CO., LTD.1N2026-01-014F., No. 118, Gongye 9th Rd., Dali Dist. Taichung TW 41280

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2120951271423865K242830LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality AnalyzerPOV2025-05-30
2120951209607404K242388LensHooke X12 PRO Semen Analysis SystemPOV2025-05-09
2120951071299779K221810LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation DeviceMQK2022-10-31
2120951528742315K202089LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality AnalyzerPOV2020-10-28
2120951649193863K180343LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality AnalyzerPOV2018-11-16
21209512092150731969-12-31
21209512092150731969-12-31
21209512092150731969-12-31
21209512092150731969-12-31
21209513382208051969-12-31
21209513382208051969-12-31
21209513382208051969-12-31
21209513382208051969-12-31
2120951054380528
2120951191534001
2120951380386612
2120951557419124
2120951650553059
2120951847980926

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
POV42025-05-30
MQK12022-10-31

PMA

PMN

Applications

GUDID