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Bonraybio Co., Ltd.

Taiwan · Taichung City · www.lenshooke.com

✓ Record-verifiedregistrations found in 10 marketsEU SRN TW-MF-000029512

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Singapore, South Korea, Australia, Israel, Russia — 10 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

pendingnot queried

EUEuropean UnionEUDAMED

37UDI-DI device records

Class I 3Class IIb 1IVD A 32IVD general 1

USUnited StatesFDA openFDA

9listed device types

Class I 5Class II 4Class III 0

plus 11 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

8registered device records

Class I 1Class IIb 1IVD A 6

BRBrazilANVISA

8registered devices

Class II 8

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

2 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

3device registrations

CLASS B 3

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

IVD import 1

AUAustraliaTGA ARTG

4active ARTG entries

IVD Class 1 2IVD Class 2 1IIa 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

1active registrations

Class 2a 1

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

European Union37 raw hits, 0 excluded, 37 confirmed

United States11 registration records, 5 510(k), 0 PMA, 1 excluded

United Kingdom8 confirmed, 0 excluded

Brazil8 confirmed, 0 excluded

Manufacturer names merged into this page: BONRAYBIO CO., LTD. · BONRAYBIO CO., L TD.

Regulatory identity

EU manufacturer SRN: TW-MF-000029512
EU authorised representative: MDSS GmbH
UK responsible person: MDSS-UK RP LIMITED

FDA 510(k) clearances by year

12018 · K180343

12020 · K202089

12022 · K221810

22025 · K242830

FDA listed device types

showing 8 of 9

Hemocytometer 1Container, Specimen, Non-Sterile 1Trypsin 1Wright'S Stain 1Stains, Hematology 1Counter, Differential Cell 1Semen Analysis Device 1Material, Quality Control, Semen Analysis 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	04719874744069	LensHooke® Data Consolidation Software	IVD A
EU	04719874741747	LensHooke® Sperm Double Strand DNA Fragmentation Test Kit (SDFR assay)	IVD A
EU	14719874740631	LensHooke® Semen Test Cassette	IVD A
EU	04719874740818	LensHooke® X QC Beads (For Semen)	IVD A
UK	45171	LensHooke® CW0 Cleaning Wipe	Class I
UK	63772	C-KUP® Liquefaction Test Cup	IVD A
UK	42703	LensHooke® Liquefaction Enzyme	IVD A
US	K242830	LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer	2025-05-30
US	K242388	LensHooke X12 PRO Semen Analysis System	2025-05-09
US	K221810	LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device	2022-10-31
BR	81931150019	Kit de Teste Rápido de Fragmentação de DNA de Esperma LensHooke® (ensa	Class II
BR	81931150020	Kit de Teste Rápido de Fragmentação de DNA Dupla Hélice em Espermatozó	Class II
BR	81931150021	Analisador da Qualidade de Sêmen LensHooke® X3 PRO	Class II

Bonraybio Co., Ltd.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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