510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Bonraybio Co., Ltd.

Taichung, TW

BONRAYBIO CO., LTD. appears in FDA device records in Taichung, TW. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
5
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 5 510(k) clearances for Bonraybio Co., Ltd. between 2018 and 2025. The busiest year on record is 2025, with 2. The most recent is 2025, with 2.

Clearances by year, as a table
510(k) clearance decisions for Bonraybio Co., Ltd., by decision year
YearClearances
20181
20201
20221
20252
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K242830LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality AnalyzerPOVSubstantially Equivalent
K242388LensHooke X12 PRO Semen Analysis SystemPOVSubstantially Equivalent
K221810LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation DeviceMQKSubstantially Equivalent
K202089LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality AnalyzerPOVSubstantially Equivalent
K180343LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality AnalyzerPOVSubstantially Equivalent

Registered establishments

FDA registered establishments for Bonraybio Co., Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30140535173014053517BONRAYBIO CO., LTD.4F., No. 118, Gongye 9th Rd., Dali Dist., Taichung 41280 TW2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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Data as of , FDA export datePage updated Source: openFDA, public domain