AXESS VISION TECHNOLOGY

Address:Zone de la Liodiere,Joue Les Tours Indre-et-Loire,FR

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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

Bronchoscope (Flexible Or Rigid) (EOQ) (3)

Premarket Exempt

Clear

Broncoflex Vortex - 03664977010034 Catalog Number : 10030001

Device Description : Broncoflex Vortex is a single-use video-bronchoscope which is part of a system m Broncoflex Vortex is a single-use video-bronchoscope which is part of a system made up of the endoscope (Broncoflex) and its reusable display monitor (Screeni). Min. purchase is 5 pcs. = 1 box

Device Class :

Duns Number: 285985615

Premarket Exempt : No

Product Code : EOQ

Prescription Use : Yes

Device Count : 1

Broncoflex Agile - 03664977020033 Catalog Number : 20030001

Device Description : Broncoflex Agile is a single-use video-bronchoscope which is part of a system ma Broncoflex Agile is a single-use video-bronchoscope which is part of a system made up of the endoscope (Broncoflex) and its reusable monitor (Screeni). Min. purchase is 5 pcs. = 1 box

Device Class :

Duns Number: 285985615

Premarket Exempt : No

Product Code : EOQ

Prescription Use : Yes

Device Count : 1

Screeni - 03664977030032 Catalog Number : 30030001

Device Description : Screeni is a non-sterile reusable medical device. It is a video processor with i Screeni is a non-sterile reusable medical device. It is a video processor with integrated touch interface designed to display live imaging data captured by sterile disposable endoscopes (Broncoflex Agile or Vortex).

Device Class : 2

Duns Number: 285985615

Premarket Exempt : No

Product Code : EOQ

Prescription Use : Yes

Device Count : 1

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