REMEDI CO.,LTD.

Address:2F, 69-14, Sakju-ro 145beon-gil,Chuncheon Gangwon,KR

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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) Unit, X-Ray, Extraoral With Timer (EHD) (2) System, X-Ray, Angiographic (IZI) (1)

Premarket Exempt

Clear

MobileX Portable X-Ray System - 08800060100007 Catalog Number :

Device Class : 2

Duns Number: 690072489

Premarket Exempt : No

Product Code : EHD

Prescription Use : No

Device Count : 1

Intraoral X-ray sensor - 08800060100052 Catalog Number :

Device Class : 2

Duns Number: 690072489

Premarket Exempt : No

Product Code : MUH

Prescription Use : No

Device Count : 1

Intraoral X-ray sensor - 08800060100069 Catalog Number :

Device Class : 2

Duns Number: 690072489

Premarket Exempt : No

Product Code : MUH

Prescription Use : No

Device Count : 1

REMEX T100 - 08800060100144 Catalog Number :

Device Class : 2

Duns Number: 690072489

Premarket Exempt : No

Product Code : EHD

Prescription Use : No

Device Count : 1

REMEX KA6 - 08800060100151 Catalog Number :

Device Class : 2

Duns Number: 690072489

Premarket Exempt : No

Product Code : IZI

Prescription Use : No

Device Count : 1

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