Mölnlycke Health Care AB

Address:Gamlestadsvagen 3C, Box 13080,Goteborg Vastra Gotaland,SE

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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

Dressing, wound, hydrophilic (NAC) (7) Surgeon's gloves (KGO) (1)

Premarket Exempt

No Yes

Clear

Biogel PI Pro-Fit® - 07332551976910 Catalog Number :

Device Description : Biogel PI Pro-Fit 9.0x40

Device Class :

Duns Number: 631770658

Premarket Exempt : No

Product Code : KGO

Prescription Use : No

Device Count : 1

Lyofoam® Max T - 07332551999759 Catalog Number :

Device Description : Lyofoam Max T 9cmx9cm x 10pcs

Device Class :

Duns Number: 631770658

Premarket Exempt : Yes

Product Code : NAC

Prescription Use : No

Device Count : 1

Mepilex® Up - 07333350001643 Catalog Number :

Device Description : Mepilex Up, 20x20 cm US

Device Class :

Duns Number: 631770658

Premarket Exempt : Yes

Product Code : NAC

Prescription Use : No

Device Count : 1

Mepilex® Lite - 07333350202842 Catalog Number :

Device Description : Mepilex Lite 12.5x12.5cm

Device Class : 1

Duns Number: 631770658

Premarket Exempt : Yes

Product Code : NAC

Prescription Use : No

Device Count : 1

Mepilex® Up - 07333350294755 Catalog Number :

Device Description : Mepilex Up, 10x10 cm US

Device Class : 1

Duns Number: 631770658

Premarket Exempt : Yes

Product Code : NAC

Prescription Use : No

Device Count : 1

Mepilex® Border Flex - 07333350370565 Catalog Number :

Device Description : Mepilex Border Flex 7,5x7,5cm

Device Class : 1

Duns Number: 631770658

Premarket Exempt : Yes

Product Code : NAC

Prescription Use : No

Device Count : 1

Mepilex® Up - 07333350795542 Catalog Number :

Device Description : Mepilex Up, 15x15 cm US

Device Class : 1

Duns Number: 631770658

Premarket Exempt : Yes

Product Code : NAC

Prescription Use : No

Device Count : 1

Mepilex® Up - 07333350835828 Catalog Number :

Device Description : Mepilex Up, 10x20 cm US

Device Class :

Duns Number: 631770658

Premarket Exempt : Yes

Product Code : NAC

Prescription Use : No

Device Count : 1

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