BONRAYBIO CO., LTD.

Address:4F., No. 118, Gongye 9th Rd., Dali Dist.,Taichung,TW

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Material, Quality Control, Semen Analysis (NRF) (9) Semen Analysis Device (POV) (1)

Premarket Exempt

No Yes

Clear

LensHooke Semen Quality Analyzer - 04719874740702 Catalog Number :

Device Class : 2

Duns Number: 658872369

Premarket Exempt : No

Product Code : POV

Prescription Use : Yes

Device Count : 1

LensHooke X QC Beads (For Semen) - 04719874740733 Catalog Number :

Device Class : 2

Duns Number: 658872369

Premarket Exempt : Yes

Product Code : NRF

Prescription Use : No

Device Count : 1

LensHooke X QC Reticle (For Semen) - 04719874740832 Catalog Number : X QC Reticle

Device Description : 04719874740849 LensHooke X QC Reticle (For Semen)- L004719874740856 LensHooke X 04719874740849 LensHooke X QC Reticle (For Semen)- L004719874740856 LensHooke X QC Reticle (For Semen)- L104719874740863 LensHooke X QC Reticle (For Semen)- L2For US

Device Class : 2

Duns Number: 658872369

Premarket Exempt : Yes

Product Code : NRF

Prescription Use : No

Device Count : 1

LensHooke X QC Reticle (For Semen) - 04719874740849 Catalog Number : X QC Reticle

Device Class : 2

Duns Number: 658872369

Premarket Exempt : Yes

Product Code : NRF

Prescription Use : No

Device Count : 1

LensHooke X QC Reticle (For Semen) - 04719874740856 Catalog Number : X QC Reticle

Device Class : 2

Duns Number: 658872369

Premarket Exempt : Yes

Product Code : NRF

Prescription Use : No

Device Count : 1

LensHooke X QC Reticle (For Semen) - 04719874740863 Catalog Number : X QC Reticle

Device Class : 2

Duns Number: 658872369

Premarket Exempt : Yes

Product Code : NRF

Prescription Use : No

Device Count : 1

LensHooke X QC Reticle (For Semen) - 04719874740870 Catalog Number : X QC Reticle

Device Description : 04719874740887 LensHooke X QC Reticle (For Semen)-L004719874740894 LensHooke X Q 04719874740887 LensHooke X QC Reticle (For Semen)-L004719874740894 LensHooke X QC Reticle (For Semen)-L104719874740900 LensHooke X QC Reticle (For Semen)-L2For BR USA CORP.

Device Class : 2

Duns Number: 658872369

Premarket Exempt : Yes

Product Code : NRF

Prescription Use : No

Device Count : 1

LensHooke X QC Reticle (For Semen) - 04719874740887 Catalog Number : X QC Reticle

Device Class : 2

Duns Number: 658872369

Premarket Exempt : Yes

Product Code : NRF

Prescription Use : No

Device Count : 1

LensHooke X QC Reticle (For Semen) - 04719874740894 Catalog Number : X QC Reticle

Device Class : 2

Duns Number: 658872369

Premarket Exempt : Yes

Product Code : NRF

Prescription Use : No

Device Count : 1

LensHooke X QC Reticle (For Semen) - 04719874740900 Catalog Number : X QC Reticle

Device Class : 2

Duns Number: 658872369

Premarket Exempt : Yes

Product Code : NRF

Prescription Use : No

Device Count : 1

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