Kerecis Limited

Iceland IS-MF-000001365 Last updated 21 Oct 2026

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Devices: 13
Registries: EUDAMEDFDA 510(k)FDA
FDA recalls: 0

Catalogue13

MariSurgi Ref 50205S00D0B

Class III EUDAMED Active
Kerecis Reconstruct Ref K202430

Class II FDA 510(k) Active
Kerecis SurgiBind (50241) Ref K251844

Class II FDA 510(k) Active
Marigen Wound Dressing Ref K132343

Unclassified FDA 510(k) Active
Kerecis Gingiva Graft Ref K192612

Class II FDA 510(k) Active
Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus Ref K251845

Unclassified FDA 510(k) Active
Kerecis SecureMesh Ref K153364

Class II FDA 510(k) Active
Tendon Protect (50242) Ref K243843

Class II FDA 510(k) Active
Kerecis Parvus (50207) Ref K241080

Unclassified FDA 510(k) Active
Kerecis Silicone Ref K213231

Unclassified FDA 510(k) Active
MariGen Wound Extra Ref K190528

Unclassified FDA 510(k) Active
Kerecis™ Omega3 Wound Ref 50200S00B0B

Class III EUDAMED Active
Kerecis Omega3 Wound Ref 50200S02B0B

Class III EUDAMED Active

EUDAMED certificates2

Held under this manufacturer's EUDAMED registration, grouped by notified body; in force first, then by expiry.

Notified body 0344 2 certificates

2258709CE01 Issued

Quality management system EU MDR

Issued
8 Jan 2026

Expires
1 Oct 2030
2258709TD01 Supplemented

Technical documentation EU MDR

Issued
3 Jun 2026

Expires
1 Oct 2030

Reason
Change approved

Notified bodies

Notified body 0344

FDA establishments1

Registered with the FDA under this company group, matched by name.

Kerecis IS

About

The intact Kerecis fish skin is being used to treat wounds, burns and other complex acute and chronic wounds including diabetic, venous, trauma, and surgical wounds. Thousands of patients of all incomes, cultures and races have benefited from treatment with Kerecis.

From the manufacturer's own website. Source

Information

Country: Iceland
Address: 2, Eyrargata, Isafjördur, Iceland
Website: www.kerecis.com
LinkedIn: linkedin.com/company/kerecis/posts
Facebook: facebook.com/kerecis
Email: [email protected]
Phone: +354 419 8000
PRRC contact: Skuli Magnusson
EUDAMED SRN: IS-MF-000001365

Catalogue13

MariSurgi Ref 50205S00D0B

Kerecis Reconstruct Ref K202430

Kerecis SurgiBind (50241) Ref K251844

Marigen Wound Dressing Ref K132343

Kerecis Gingiva Graft Ref K192612

Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus Ref K251845

Kerecis SecureMesh Ref K153364

Tendon Protect (50242) Ref K243843

Kerecis Parvus (50207) Ref K241080

Kerecis Silicone Ref K213231

MariGen Wound Extra Ref K190528

Kerecis™ Omega3 Wound Ref 50200S00B0B

Kerecis Omega3 Wound Ref 50200S02B0B