M.I.Tech Co., Ltd.

Address:174, Habuk 2gil, Jinwimyeon,Pyeongtaek Gyeonggi,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

Prosthesis, Esophageal (ESW) (9) Catheter, Biliary, Diagnostic (FGE) (1)

Premarket Exempt

Clear

HANAROSTENT® Esophagus (CCC) - 08806367004130 Catalog Number :

Device Class : 2

Duns Number: 688454359

Premarket Exempt : No

Product Code : ESW

Prescription Use : Yes

Device Count : 1

HANAROSTENT® Esophagus (CCC) - 08806367004147 Catalog Number :

Device Description : Full Covered metallic esophagus stent

Device Class : 2

Duns Number: 688454359

Premarket Exempt : No

Product Code : ESW

Prescription Use : Yes

Device Count : 1

HANAROSTENT® Esophagus (CCC) - 08806367004161 Catalog Number :

Device Description : Full Covered metallic esophagus stent

Device Class : 2

Duns Number: 688454359

Premarket Exempt : No

Product Code : ESW

Prescription Use : Yes

Device Count : 1

HANAROSTENT® Esophagus (CCC) - 08806367004178 Catalog Number :

Device Description : Full Covered metallic esophagus stent

Device Class : 2

Duns Number: 688454359

Premarket Exempt : No

Product Code : ESW

Prescription Use : Yes

Device Count : 1

HANAROSTENT® Esophagus (CCC) - 08806367004185 Catalog Number :

Device Description : Full Covered metallic esophagus stent

Device Class : 2

Duns Number: 688454359

Premarket Exempt : No

Product Code : ESW

Prescription Use : Yes

Device Count : 1

HANAROSTENT® Esophagus (CCC) - 08806367004192 Catalog Number :

Device Description : Full Covered metallic esophagus stent

Device Class : 2

Duns Number: 688454359

Premarket Exempt : No

Product Code : ESW

Prescription Use : Yes

Device Count : 1

HANAROSTENT® Esophagus (CCC) - 08806367004208 Catalog Number :

Device Description : Full Covered metallic esophagus stent

Device Class : 2

Duns Number: 688454359

Premarket Exempt : No

Product Code : ESW

Prescription Use : Yes

Device Count : 1

HANAROSTENT® Esophagus (CCC) - 08806367004215 Catalog Number :

Device Description : Full Covered metallic esophagus stent

Device Class : 2

Duns Number: 688454359

Premarket Exempt : No

Product Code : ESW

Prescription Use : Yes

Device Count : 1

HANAROSTENT® Esophagus (CCC) - 08806367004222 Catalog Number :

Device Description : Full Covered metallic esophagus stent

Device Class : 2

Duns Number: 688454359

Premarket Exempt : No

Product Code : ESW

Prescription Use : Yes

Device Count : 1

HANAROSTENT® Biliary (NNN) - 08806367017383 Catalog Number :

Device Description : Un-covered self-expanding nitinol biliary stent

Device Class : 2

Duns Number: 688454359

Premarket Exempt : No

Product Code : FGE

Prescription Use : Yes

Device Count : 1

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