Coloplast A/S

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

Bandage, liquid, skin protectant (NEC) (6) Dressing, wound and burn, hydrogel w/drug and/or biologic (MGQ) (2) Dressing, wound, hydrophilic (NAC) (2)

Premarket Exempt

No Yes

Clear

COLOPLAST PREP - 00311701007039 Catalog Number : 0925

Device Description : Skin Barrier Wipe

Device Class : 1

Duns Number: 305524696

Premarket Exempt : Yes

Product Code : NEC

Prescription Use : No

Device Count : 1

Coloplast - 00311701007206 Catalog Number : 62041

Device Description : Coloplast® Prep Barrier Film / Coloplast Prep Barrier Film / Prep Prep Barrier Film.

Device Class :

Duns Number: 305524696

Premarket Exempt : Yes

Product Code : NEC

Prescription Use : No

Device Count : 1

TRIAD - 00311701031324 Catalog Number : 1967

Device Description : Hydrophilic paste

Device Class : 1

Duns Number: 305524696

Premarket Exempt : Yes

Product Code : NAC

Prescription Use : No

Device Count : 1

TRIAD - 00311701031331 Catalog Number : 1964

Device Description : Triad

Device Class : 1

Duns Number: 305524696

Premarket Exempt : Yes

Product Code : NAC

Prescription Use : No

Device Count : 1

Sea-Clens - 00311701159356 Catalog Number : 1061

Device Description : No-Rinse Cleanser

Device Class : 1

Duns Number: 305524696

Premarket Exempt : Yes

Product Code : NEC

Prescription Use : No

Device Count : 1

SEA-CLENS - 00311701159363 Catalog Number : 1063

Device Description : No-rinse cleanser

Device Class : 1

Duns Number: 305524696

Premarket Exempt : Yes

Product Code : NEC

Prescription Use : No

Device Count : 1

WOUN'DRES - 00311701161021 Catalog Number : 1166

Device Class : U

Duns Number: 305524696

Premarket Exempt : No

Product Code : MGQ

Prescription Use : No

Device Count : 1

WOUN'DRES - 00311701161168 Catalog Number : 7690

Device Description : Collagen hydrogel

Device Class : U

Duns Number: 305524696

Premarket Exempt : No

Product Code : MGQ

Prescription Use : No

Device Count : 1

Coloplast - 00762123001073 Catalog Number : 2310

Device Description : Coloplast Rings. Pre-cut 10 mm.

Device Class :

Duns Number: 305524696

Premarket Exempt : Yes

Product Code : NEC

Prescription Use : No

Device Count : 30

Coloplast - 00762123001080 Catalog Number : 2315

Device Description : Coloplast Rings. Pre-cut 15 mm

Device Class :

Duns Number: 305524696

Premarket Exempt : Yes

Product Code : NEC

Prescription Use : No

Device Count : 30

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