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
Model / Reference: Expanse 4x4 cm FDA UDI

Identifiers

Catalog Number: 50200N44B0D FDA UDI
Primary DI / UDI-DI: 05694310964500 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 — 4 Centimeter FDA UDI
Length — 3 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

Similar devices

Also classified as Animal-derived wound matrix dressing.

PuraPly™ Antimicrobial XT Wound Matrix — ORGANOGENESIS INC. · Class I
DermaCol/Ag Healogics by DermaRite — DERMARITE INDUSTRIES LLC · U
Myriad Matrix™ Soft Tissue Bioscaffold — Aroa Biosurgery · U
HealiAid Collagen Wound Dressing — MAXIGEN BIOTECH INC. · U
Solventum™ Promogran™ — Solventum US LLC · U
Simpurity — SAFE N SIMPLE LLC · U
ProgenaMatrix — Progenacare Global, LLC · U
INTEGRA® — Integra Lifesciences Corp. · U

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 6a08e37b-ea21-4ce5-8e86-2d744b640f73 37 fields · synced Jun 8, 2026