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BONRAYBIO CO., LTD.

Taiwan·TW-MF-000029512

Last updated September 17, 2026

Information

Country: Taiwan
Address: 4F., No. 118, Gongye 9th Rd., Dali Dist., Taichung, Taiwan
Website: bonraybio.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: YJ Liao
EUDAMED SRN: TW-MF-000029512
FDA FEI Number: 3014053517
DUNS Number: 658872369

Catalogue (85)

Page 2 of 2

Device	Model / Reference	Registries	Class	Status
LensHooke X QC Slide (For Semen)	QXC Package-pcs-L1-US-HT	FDA UDI	Class II	Active
LensHooke Cleaning Wipe	CW1_Cleaning Wipe Package-10pcs-US_HT	FDA UDI	Class II	Active
LensHooke Sperm Double Strand DNA Fragmentation Rapid Test Kit (SDFR assay)	R11 Plus Package-10 tests-US-BR	FDA UDI	Class I	Active
LensHooke Prestained Morphology Slide	CR0 Package-50pcs-US-HT	FDA UDI	Class I	Active
LensHooke Semen Test Slide	CS3 Package-250pcs-US-HT	FDA UDI	Class I	Active
LensHooke X QC Reticle (For Semen)	X QC Reticle - L0_US	FDA UDI	Class II	Active
LensHooke Semen Quality Analyzer	X1 PRO	FDA UDI	Class II	Active
LensHooke X QC Reticle (For Semen)	X QC Reticle - 3 in1_US	FDA UDI	Class II	Active
LensHooke semen Test Cassette	CS1_400pcs_BR USA CORP.	FDA UDI	Class II	Active
LensHooke X QC Slide (For Semen)	QXC Package-3pcs-US	FDA UDI	Class II	Active
LensHooke Semen Test Slide	CS3 Package-250pcs-US-BR	FDA UDI	Class I	Active
LensHooke Semen Test Slide	CS3 Package-25pcs-US-BR	FDA UDI	Class I	Active
LensHooke® Semen Analysis System	X12 PRO	EUDAMED	Class A	Active
LensHooke® Sperm DNA Fragmentation Test Kit (SCD Assay)	R10	EUDAMED	Class A	Active
LensHooke® X QC Video (For Semen)	X QC Video	EUDAMED	Class A	Active
LensHooke® X1 PRO Semen Quality Analyzer	X1 PRO	EUDAMED	Class A	Active
LensHooke® Sperm Double Strand DNA Fragmentation Rapid Test Kit (SDFR assay)	R11 Plus	EUDAMED	Class A	Active
LensHooke® Semen Test Cassette	CS1	EUDAMED	Class A	Active
LensHooke® Sperm DNA Fragmentation Rapid Test Kit (SCD Assay)	R10 Plus	EUDAMED	Class A	Active
LensHooke® X1 PRO Semen Quality Analyzer	X1 PRO	EUDAMED	Class A	Active
LensHooke® CW0 Cleaning Wipe	CW0	EUDAMED	Class I	Active
LensHooke® Cleaning Wipe	CW1	EUDAMED	Class I	Active
LensHooke® X QC Beads (For Semen)	X QC Beads	EUDAMED	Class A	Active
LensHooke® X3 PRO Semen Quality Analyzer	X3 PRO	EUDAMED	Class A	Active
LensHooke® X QC Reticle (For Semen)	X QC Reticle	EUDAMED	Class A	Active
LensHooke® X QC Slide (For Semen)	X QC Slide	EUDAMED	Class A	Active
LensHooke® X QC Video (For Semen)	X QC Video	EUDAMEDFDA UDI	Class A	Active
LensHooke® X QC Reticle (For Semen)	X QC Reticle	EUDAMED	Class A	Active
LensHooke® X QC Video (For Semen)	X QC Video	EUDAMEDFDA UDI	Class A	Active
C-KUPTM Liquefaction Test Cup	CK0	EUDAMED	Class A	Active
LensHooke® Prestained Morphology Slide	CR0	EUDAMED	Class A	Active
LensHooke® X QC Video (For Semen)	X QC Video	EUDAMEDFDA UDI	Class A	Active
LensHooke® Sperm Separation Device	CA0	EUDAMED	Class IIb	Active
LensHooke® Semen Analysis System	X12 PRO	EUDAMED	Class A	Active
LensHooke® Cleaning Wipe Holder	CWA	EUDAMED	Class I	Active

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