S.I.M.E.O.N. Medical GmbH & Co. KG

Address:In Grubenacker 18,TUTTLINGEN Baden-Wurttemberg,DE

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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

Light, Surgical, Ceiling Mounted (FSY) (7) Light, Surgical, Floor Standing (FSS) (1)

Premarket Exempt

Yes

Clear

Sim.LED 5000 SC 5p LC 160klx - 04250613845383 Catalog Number :

Device Description : Sim.LED 5000 SC 5pole low ceiling 160,000 lux

Device Class : 2

Duns Number: 344838128

Premarket Exempt : Yes

Product Code : FSY

Prescription Use : No

Device Count : 1

Sim.LED 5000 SC 9p 160klx - 04250613845390 Catalog Number :

Device Description : Sim.LED 5000 SC 9pole 160,000 lux

Device Class : 2

Duns Number: 344838128

Premarket Exempt : Yes

Product Code : FSY

Prescription Use : No

Device Count : 1

Sim.LED 5000 SC 9p LC 160klx - 04250613845406 Catalog Number :

Device Description : Sim.LED 5000 SC 9pole low ceiling 160,000 lux

Device Class : 2

Duns Number: 344838128

Premarket Exempt : Yes

Product Code : FSY

Prescription Use : No

Device Count : 1

Sim.LED 5000 MC 3p LC 160klx - 04250613845420 Catalog Number :

Device Description : Sim.LED 5000 Multi-Color 3pole low ceiling 160,000 lux

Device Class : 2

Duns Number: 344838128

Premarket Exempt : Yes

Product Code : FSY

Prescription Use : No

Device Count : 1

Sim.LED 5000 MC 5p 160klx - 04250613845437 Catalog Number :

Device Description : Sim.LED 5000 Multi-Color 5pole 160,000 lux

Device Class : 2

Duns Number: 344838128

Premarket Exempt : Yes

Product Code : FSY

Prescription Use : No

Device Count : 1

Sim.LED 5000 MC 5p LC 160klx - 04250613845444 Catalog Number :

Device Description : Sim.LED 5000 Multi-Color 5pole low ceiling 160,000 lux

Device Class : 2

Duns Number: 344838128

Premarket Exempt : Yes

Product Code : FSY

Prescription Use : No

Device Count : 1

Sim.LED 5000 MC 9p LC 160klx - 04250613845451 Catalog Number :

Device Description : Sim.LED 5000 Multi-Color 9pole low ceiling 160,000 lux

Device Class : 2

Duns Number: 344838128

Premarket Exempt : Yes

Product Code : FSY

Prescription Use : No

Device Count : 1

Adp MS SA MZ - 04250613845918 Catalog Number :

Device Description : Adapter for mobile stand

Device Class : 2

Duns Number: 344838128

Premarket Exempt : Yes

Product Code : FSS

Prescription Use : No

Device Count : 1

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