SIS AG, Surgical Instrument Systems

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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

Keratome, Ac-Powered (HNO) (2) Device, Analysis, Anterior Segment (MXK) (1) Device,Analysis,Anterior Segment (MXK) (1)

Premarket Exempt

Clear

AMADEUS - 07640167751198 Catalog Number : 130.700.020

Device Description : Sterile vacuum tube for AMADEUS

Device Class :

Duns Number: 480508261

Premarket Exempt : No

Product Code : HNO

Prescription Use : Yes

Device Count : 10

AMADEUS - 07640167751211 Catalog Number : 130.700.001

Device Description : SurePass sterile blade for AMADEUS

Device Class :

Duns Number: 480508261

Premarket Exempt : No

Product Code : HNO

Prescription Use : Yes

Device Count : 10

GALILEI - 07640167751235 Catalog Number : 410.030.004

Device Description : Galilei Dual Scheimpflug Analyzer

Device Class : 2

Duns Number: 480508261

Premarket Exempt : No

Product Code : MXK

Prescription Use : Yes

Device Count : 1

GALILEI - 07640167751242 Catalog Number : 410.030.007

Device Description : Galilei G6 Lens Professional

Device Class : 2

Duns Number: 480508261

Premarket Exempt : No

Product Code : MXK

Prescription Use : Yes

Device Count : 1

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