Ellipse A/S

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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

Powered Laser Surgical Instrument (GEX) (4) Powered Light Based Non-Laser Surgical Instrument With Thermal Effect (ONF) (4)

Premarket Exempt

Clear

Ellipse Nordlys - 05713530000475 Catalog Number :

Device Class : 2

Duns Number: 305006145

Premarket Exempt : No

Product Code : GEX, ONF

Prescription Use : Yes

Device Count : 1

Ellipse Nordlys USA - 05713530000482 Catalog Number :

Device Class : 2

Duns Number: 305006145

Premarket Exempt : No

Product Code : GEX, ONF

Prescription Use : Yes

Device Count : 1

Ellipse Sirius - 05713530000499 Catalog Number :

Device Class : 2

Duns Number: 305006145

Premarket Exempt : No

Product Code : GEX, ONF

Prescription Use : Yes

Device Count : 1

Ellipse Sirius USA - 05713530000505 Catalog Number :

Device Class : 2

Duns Number: 305006145

Premarket Exempt : No

Product Code : GEX, ONF

Prescription Use : Yes

Device Count : 1

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