FINEMEDIX CO.,LTD.

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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

Biopsy Needle (FCG) (5) Hemostatic Metal Clip For The Gi Tract (PKL) (2)

Premarket Exempt

No Yes

Clear

ClearTip - 08809327352937 Catalog Number :

Device Description : EUS-FNA 22G

Device Class : 2

Duns Number: 688256864

Premarket Exempt : No

Product Code : FCG

Prescription Use : Yes

Device Count : 1

ClearTip - 08809327352944 Catalog Number :

Device Description : EUS-FNA 25G

Device Class : 2

Duns Number: 688256864

Premarket Exempt : No

Product Code : FCG

Prescription Use : Yes

Device Count : 1

ClearTip - 08809327352951 Catalog Number :

Device Description : EUS-FNB 19G

Device Class : 2

Duns Number: 688256864

Premarket Exempt : No

Product Code : FCG

Prescription Use : Yes

Device Count : 1

ClearTip - 08809327352968 Catalog Number :

Device Description : EUS-FNB 22G

Device Class : 2

Duns Number: 688256864

Premarket Exempt : No

Product Code : FCG

Prescription Use : Yes

Device Count : 1

ClearTip - 08809327352975 Catalog Number :

Device Description : EUS-FNB 25G

Device Class : 2

Duns Number: 688256864

Premarket Exempt : No

Product Code : FCG

Prescription Use : Yes

Device Count : 1

ClearEndoclip - 08809327353088 Catalog Number :

Device Description : 11mm/90°/1650mm

Device Class : 2

Duns Number: 688256864

Premarket Exempt : No

Product Code : PKL

Prescription Use : Yes

Device Count : 1

ClearEndoclip - 08809327353095 Catalog Number :

Device Description : 11mm/90°/2300mm

Device Class : 2

Duns Number: 688256864

Premarket Exempt : No

Product Code : PKL

Prescription Use : Yes

Device Count : 1

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