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

System, X-Ray, Stationary (KPR) (10)

Premarket Exempt

No Yes

Clear

DRGEM - 08800011120016 Catalog Number :

Device Description : 220-230V~ / 150kV

Device Class : 2

Duns Number: 688477319

Premarket Exempt : No

Product Code : KPR

Prescription Use : Yes

Device Count : 1

DRGEM - 08800011120023 Catalog Number :

Device Description : 220-230V~ / 125kV

Device Class : 2

Duns Number: 688477319

Premarket Exempt : No

Product Code : KPR

Prescription Use : Yes

Device Count : 1

DRGEM - 08800011120030 Catalog Number :

Device Description : 220-230V~ / 150kV

Device Class : 2

Duns Number: 688477319

Premarket Exempt : No

Product Code : KPR

Prescription Use : Yes

Device Count : 1

DRGEM - 08800011120047 Catalog Number :

Device Description : 400V3~ / 150kV

Device Class : 2

Duns Number: 688477319

Premarket Exempt : No

Product Code : KPR

Prescription Use : Yes

Device Count : 1

DRGEM - 08800011120054 Catalog Number :

Device Description : 400V3~ / 150kV

Device Class : 2

Duns Number: 688477319

Premarket Exempt : No

Product Code : KPR

Prescription Use : Yes

Device Count : 1

DRGEM - 08800011120061 Catalog Number :

Device Description : 400V3~ / 150kV

Device Class : 2

Duns Number: 688477319

Premarket Exempt : No

Product Code : KPR

Prescription Use : Yes

Device Count : 1

DRGEM - 08800011120078 Catalog Number :

Device Description : 110-120V~ / 125kV

Device Class : 2

Duns Number: 688477319

Premarket Exempt : No

Product Code : KPR

Prescription Use : Yes

Device Count : 1

DRGEM - 08800011120085 Catalog Number :

Device Description : 110-120V~ / 125kV

Device Class : 2

Duns Number: 688477319

Premarket Exempt : No

Product Code : KPR

Prescription Use : Yes

Device Count : 1

DRGEM - 08800011120092 Catalog Number :

Device Description : 110-120V~ / 125kV

Device Class : 2

Duns Number: 688477319

Premarket Exempt : No

Product Code : KPR

Prescription Use : Yes

Device Count : 1

DRGEM - 08800011120108 Catalog Number :

Device Description : 100-240V~ / 125kV

Device Class : 2

Duns Number: 688477319

Premarket Exempt : No

Product Code : KPR

Prescription Use : Yes

Device Count : 1

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