DRGEM Corporation

DRGEM Corporation

Address:116-59, Sanho-daero,Gumi-si Gyeongbuk,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

Table, Radiographic, Non-Tilting, Powered (IZZ) (4) Holder, Radiographic Cassette, Wall-Mounted (IXY) (3) Tube Mount, X-Ray, Diagnostic (IYB) (3)

Premarket Exempt

No Yes

Clear

DRGEM - 08800011100018 Catalog Number :

Device Class : 2

Duns Number: 688477319

Premarket Exempt : Yes

Product Code : IZZ

Prescription Use : Yes

Device Count : 1

DRGEM - 08800011101008 Catalog Number :

Device Class : 2

Duns Number: 688477319

Premarket Exempt : Yes

Product Code : IZZ

Prescription Use : Yes

Device Count : 1

DRGEM - 08800011101015 Catalog Number :

Device Class : 2

Duns Number: 688477319

Premarket Exempt : Yes

Product Code : IZZ

Prescription Use : Yes

Device Count : 1

DRGEM - 08800011101022 Catalog Number :

Device Class : 2

Duns Number: 688477319

Premarket Exempt : Yes

Product Code : IZZ

Prescription Use : Yes

Device Count : 1

DRGEM - 08800011102005 Catalog Number :

Device Class : 1

Duns Number: 688477319

Premarket Exempt : Yes

Product Code : IXY

Prescription Use : Yes

Device Count : 1

DRGEM - 08800011102012 Catalog Number :

Device Class : 1

Duns Number: 688477319

Premarket Exempt : Yes

Product Code : IXY

Prescription Use : Yes

Device Count : 1

DRGEM - 08800011102029 Catalog Number :

Device Class : 1

Duns Number: 688477319

Premarket Exempt : Yes

Product Code : IXY

Prescription Use : Yes

Device Count : 1

DRGEM - 08800011103002 Catalog Number :

Device Class : 1

Duns Number: 688477319

Premarket Exempt : Yes

Product Code : IYB

Prescription Use : Yes

Device Count : 1

DRGEM - 08800011103019 Catalog Number :

Device Class : 1

Duns Number: 688477319

Premarket Exempt : Yes

Product Code : IYB

Prescription Use : Yes

Device Count : 1

DRGEM - 08800011103026 Catalog Number :

Device Class : 1

Duns Number: 688477319

Premarket Exempt : Yes

Product Code : IYB

Prescription Use : Yes

Device Count : 1

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