BIOPTIGEN, 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

Tomography, optical coherence (OBO) (10)

Premarket Exempt

Clear

ENVISU C2300 VHR 120V - 00857691006022 Catalog Number :

Device Class : 2

Duns Number: 361420040

Premarket Exempt : No

Product Code : OBO

Prescription Use : Yes

Device Count : 1

ENVISU C2300 VHR 220V - 00857691006053 Catalog Number :

Device Class : 2

Duns Number: 361420040

Premarket Exempt : No

Product Code : OBO

Prescription Use : Yes

Device Count : 1

ENFOCUS 2300 VHR 120V - 00857691006084 Catalog Number :

Device Class : 2

Duns Number: 361420040

Premarket Exempt : No

Product Code : OBO

Prescription Use : Yes

Device Count : 1

ENFOCUS 2300 VHR 220V - 00857691006091 Catalog Number :

Device Class : 2

Duns Number: 361420040

Premarket Exempt : No

Product Code : OBO

Prescription Use : Yes

Device Count : 1

ENFOCUS 4400 HR 120V - 00857691006107 Catalog Number :

Device Class : 2

Duns Number: 361420040

Premarket Exempt : No

Product Code : OBO

Prescription Use : Yes

Device Count : 1

ENFOCUS 4400 HR 220V - 00857691006114 Catalog Number :

Device Class : 2

Duns Number: 361420040

Premarket Exempt : No

Product Code : OBO

Prescription Use : Yes

Device Count : 1

ENFOCUS 2300 VHR 100V - 00857691006336 Catalog Number :

Device Class : 2

Duns Number: 361420040

Premarket Exempt : No

Product Code : OBO

Prescription Use : Yes

Device Count : 1

ENFOCUS 4400 VHR 100V - 00857691006343 Catalog Number :

Device Class : 2

Duns Number: 361420040

Premarket Exempt : No

Product Code : OBO

Prescription Use : Yes

Device Count : 1

ENVISU C2300 VHR 100V - 00857691006367 Catalog Number :

Device Class : 2

Duns Number: 361420040

Premarket Exempt : No

Product Code : OBO

Prescription Use : Yes

Device Count : 1

ENFOCUS 2300 INTEGRATED OCT - 00857691006374 Catalog Number :

Device Class : 2

Duns Number: 361420040

Premarket Exempt : No

Product Code : OBO

Prescription Use : Yes

Device Count : 1

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