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MariGen® Compact 42 sq cm Compacted Fragmented Fish Skin

by KERECIS hf.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05694310969529 UDI-DI Date18 Sep 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
MariGen® Compact
Generic Name
Animal-derived wound matrix dressing
Model / Ref / Catalog
42 sq cm Compacted Fragmented Fish Skin, 50207T106B0D
Primary DI / UDI-DI
05694310969529
510(k) Number
FDA Product Code
KGN
GMDN Term
Animal-derived wound matrix dressing
Device Class
U
GUDID distribution status
In Commercial Distribution
Size
Area/Surface Area — 42 Square centimeter

Related devices

Cleared under the same submission (K241080)

Other devices from KERECIS hf.

See all devices from KERECIS hf. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No