Clinical Laserthermia Systems AB

Address:Scheelevagen 2,Lund Skane,SE

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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) (7) Cannula, Surgical, General & Plastic Surgery (GEA) (2) Stylet, Surgical, General & Plastic Surgery (GAH) (1)

Premarket Exempt

No Yes

Clear

MR Cannula - 17340007000475 Catalog Number :

Device Class :

Duns Number: 774856749

Premarket Exempt : Yes

Product Code : GEA

Prescription Use : Yes

Device Count : 1

MR Stylet - 17340007000482 Catalog Number :

Device Class :

Duns Number: 774856749

Premarket Exempt : Yes

Product Code : GAH

Prescription Use : Yes

Device Count : 1

Laser Applicator Non-cooled - 17340007000499 Catalog Number :

Device Class : 2

Duns Number: 774856749

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Laser Applicator Non-cooled Instructions for Use - 17340007000505 Catalog Number :

Device Class : 2

Duns Number: 774856749

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Laser Applicator Non-cooled Instructions for Use - 17340007000529 Catalog Number :

Device Class : 2

Duns Number: 774856749

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

MR Adapter TRP-IV - 17340007000536 Catalog Number :

Device Class : 1

Duns Number: 774856749

Premarket Exempt : Yes

Product Code : GEA

Prescription Use : Yes

Device Count : 1

Foot Pedal - 17340007000543 Catalog Number :

Device Class : 2

Duns Number: 774856749

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

MR Stylet - 17340007000567 Catalog Number :

Device Class :

Duns Number: 774856749

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

MR Catheter - 17340007000574 Catalog Number :

Device Class :

Duns Number: 774856749

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

MR Stylet - 17340007000581 Catalog Number :

Device Class :

Duns Number: 774856749

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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