EDLEN IMAGING, LLC

EDLEN IMAGING, LLC

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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

System,X-Ray,Extraoral Source,Digital (MUH) (2)

Premarket Exempt

No

Clear

EDLENi Dental Sensor - Size 1 - 00862973000346 Catalog Number :

Device Description : EDLENi Dental Sensor, CMOS Image Sensor, CsI Scintillator, 2.5 meter cable

Device Class : 2

Duns Number: 078801340

Premarket Exempt : No

Product Code : MUH

Prescription Use : Yes

Device Count : 1

EDLENi Dental Sensor - Size 2 - 00862973000353 Catalog Number :

Device Description : EDLENi Dental Sensor, CMOS image sensor, CsI Scintillator, 2.5 meter cable

Device Class : 2

Duns Number: 078801340

Premarket Exempt : No

Product Code : MUH

Prescription Use : Yes

Device Count : 1

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