Kerecis® MariGen™

FDA UDI

Class U (US FDA UDI)

by KERECIS hf.

Identity

Trade Name: Kerecis® MariGen™ FDA UDI
Generic Name: Animal-derived wound matrix dressing FDA UDI
Device Name: Fish-skin graft for wound management. Kerecis® MariGen™ is indicated for the management of wounds including: Partial and full-thickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, diabetic ulcers, trauma wounds (abrasions, lacerations, second-degree burns, skin tears), surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and draining wounds. IFU: https://www.kerecis.com/ifus/ifu-kerecis-marigen/ FDA UDI
Model / Reference: 3x7 cm Fenestrated FDA UDI
Description: Fish-skin graft for wound management. Kerecis® MariGen™ is indicated for the management of wounds including: Partial and full-thickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, diabetic ulcers, trauma wounds (abrasions, lacerations, second-degree burns, skin tears), surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and draining wounds. IFU: https://www.kerecis.com/ifus/ifu-kerecis-marigen/ FDA UDI

Identifiers

Catalog Number: 50200F02B0D FDA UDI
Primary DI / UDI-DI: 05694310960199 FDA UDI
510(k) Number: K132343 FDA UDI
FDA Product Code: KGN FDA UDI
GMDN Term: Animal-derived wound matrix dressing FDA UDI

Classification

Device Class: U FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Width — 3 Centimeter FDA UDI
Length — 7 Centimeter FDA UDI

Category: Animal-derived wound matrix dressing

Kerecis® MariGen™ by KERECIS hf. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Animal-derived wound matrix dressing.

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Cleared under the same submission

K132343 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class U	Pending data

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Manufacturer

Manufacturer: KERECIS hf.

Sources (1)

FDA UDI e9817e8b-979c-47a5-abad-efebc60b91f7 38 fields · synced May 30, 2026