ORIGIO INC.

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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

Microtools, Assisted Reproduction (Pipettes) (MQH) (6) Semen Analysis Device (POV) (3)

Premarket Exempt

Clear

N/A - 20888937910784 Catalog Number :

Device Description : BIOPSY MICROPIPETS

Device Class : 2

Duns Number: 787068394

Premarket Exempt : No

Product Code : MQH

Prescription Use : Yes

Device Count : 1

N/A - 20888937910807 Catalog Number :

Device Description : ICSI MICROPIPETS

Device Class : 2

Duns Number: 787068394

Premarket Exempt : No

Product Code : MQH

Prescription Use : Yes

Device Count : 1

N/A - 20888937911033 Catalog Number :

Device Description : COUNTING CHAMBER

Device Class : 2

Duns Number: 787068394

Premarket Exempt : No

Product Code : POV

Prescription Use : Yes

Device Count : 1

N/A - 20888937911569 Catalog Number :

Device Description : BIOPSY MICROPIPETS

Device Class : 2

Duns Number: 787068394

Premarket Exempt : No

Product Code : MQH

Prescription Use : Yes

Device Count : 1

N/A - 20888937911576 Catalog Number :

Device Description : BIOPSY MICROPIPETS

Device Class : 2

Duns Number: 787068394

Premarket Exempt : No

Product Code : MQH

Prescription Use : Yes

Device Count : 1

N/A - 60888937900011 Catalog Number :

Device Description : SEMEN ANALYSIS KIT

Device Class : 2

Duns Number: 787068394

Premarket Exempt : No

Product Code : POV

Prescription Use : Yes

Device Count : 1

N/A - 60888937900028 Catalog Number :

Device Description : SEMEN ANALYSIS KIT

Device Class : 2

Duns Number: 787068394

Premarket Exempt : No

Product Code : POV

Prescription Use : Yes

Device Count : 1

N/A - 60888937907799 Catalog Number :

Device Description : O-RING KIT WITH COLLET

Device Class : 2

Duns Number: 787068394

Premarket Exempt : No

Product Code : MQH

Prescription Use : Yes

Device Count : 1

N/A - 60888937907805 Catalog Number :

Device Description : O-RING KIT WITH COLLET

Device Class : 2

Duns Number: 787068394

Premarket Exempt : No

Product Code : MQH

Prescription Use : Yes

Device Count : 1

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