Coloplast A/S

Address:HOLTEDAM 1,HUMLEBAEK Hovedstaden,DK

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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

CATHETER, RETENTION TYPE, BALLOON (EZL) (10)

Premarket Exempt

No Yes

Clear

Porges Coloplast - 03600040128251 Catalog Number : AA6308

Device Description : FOLYSIL® catheter Tiemann with nylon introducer CH FR 08

Device Class : 2

Duns Number: 305524696

Premarket Exempt : No

Product Code : EZL

Prescription Use : Yes

Device Count : 1

Porges Coloplast - 03600040128381 Catalog Number : AA6310

Device Description : FOLYSIL® catheter Tiemann with nylon introducer CH FR 10

Device Class : 2

Duns Number: 305524696

Premarket Exempt : No

Product Code : EZL

Prescription Use : Yes

Device Count : 1

Porges Coloplast - 03600040128510 Catalog Number : AA6312

Device Description : FOLYSIL® catheter Tiemann CH FR 12

Device Class : 2

Duns Number: 305524696

Premarket Exempt : No

Product Code : EZL

Prescription Use : Yes

Device Count : 1

Porges Coloplast - 03600040128640 Catalog Number : AA6314

Device Description : FOLYSIL® catheter Tiemann CH FR 14

Device Class : 2

Duns Number: 305524696

Premarket Exempt : No

Product Code : EZL

Prescription Use : Yes

Device Count : 1

Porges Coloplast - 03600040128770 Catalog Number : AA6316

Device Description : FOLYSIL® catheter Tiemann CH FR 16

Device Class : 2

Duns Number: 305524696

Premarket Exempt : No

Product Code : EZL

Prescription Use : Yes

Device Count : 1

Porges Coloplast - 03600040128909 Catalog Number : AA6318

Device Description : FOLYSIL® catheter Tiemann CH FR 18

Device Class : 2

Duns Number: 305524696

Premarket Exempt : No

Product Code : EZL

Prescription Use : Yes

Device Count : 1

Porges Coloplast - 03600040129036 Catalog Number : AA6320

Device Description : FOLYSIL® catheter Tiemann CH FR 20

Device Class : 2

Duns Number: 305524696

Premarket Exempt : No

Product Code : EZL

Prescription Use : Yes

Device Count : 1

Porges Coloplast - 03600040129166 Catalog Number : AA6322

Device Description : FOLYSIL® catheter Tiemann CH FR 22

Device Class : 2

Duns Number: 305524696

Premarket Exempt : No

Product Code : EZL

Prescription Use : Yes

Device Count : 1

Porges Coloplast - 03600040129296 Catalog Number : AA6324

Device Description : FOLYSIL® catheter Tiemann CH FR 24

Device Class : 2

Duns Number: 305524696

Premarket Exempt : No

Product Code : EZL

Prescription Use : Yes

Device Count : 1

Porges Coloplast - 03600040129531 Catalog Number : AA6408

Device Description : FOLYSIL® catheter pediatric over the guide CH FR 08

Device Class : 2

Duns Number: 305524696

Premarket Exempt : No

Product Code : EZL

Prescription Use : Yes

Device Count : 1

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