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Kerecis

Iceland IS-MF-000001365 Last updated 22 Oct 2026 Part of Kerecis Limited

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Devices
2
Registries
EUDAMEDFDA 510(k)
FDA recalls
0

Catalogue2

  • MariGraft Ref 50202S02D0B

    Class III EUDAMED Active

  • MariGraft Ref 50202S24D0B

    Class III EUDAMED Active

  • MariGraft Ref 50202N35D0B

    Class III EUDAMED Active

  • MariSurgi Ref 50205N03D0B

    Class III EUDAMED Active

  • MariCell Ref 50200S04B0B

    Class III EUDAMED Active

  • MariSurgi Ref 50205S16D0B

    Class III EUDAMED Active

  • MariGraft Ref 50202S00D0B

    Class III EUDAMED Active

  • MariSurgi Ref 50205S23D0B

    Class III EUDAMED Active

  • MariGraft Ref 50202N24D0B

    Class III EUDAMED Active

  • MariGraft Ref 50202N04D0B

    Class III EUDAMED Active

  • MariSurgi Ref 50205N23D0B

    Class III EUDAMED Active

  • MariSurgi Ref 50205S04D0B

    Class III EUDAMED Active

  • MariSurgi Ref 50205N21D0B

    Class III EUDAMED Active

  • MariCell Ref 50200S21B0B

    Class III EUDAMED Active

  • MariCell Ref 50200S02B0B

    Class III EUDAMED Active

  • MariGraft Ref 50202N36D0B

    Class III EUDAMED Active

  • MariGraft Ref 50202S01D0B

    Class III EUDAMED Active

  • MariGraft Ref 50202N03D0B

    Class III EUDAMED Active

  • MariCell Ref 50200S05B0B

    Class III EUDAMED Active

  • MariGraft Ref 50202S23D0B

    Class III EUDAMED Active

  • MariCell Ref 50200S05B0B

    Class III EUDAMED Active

  • MariSurgi Ref 50205S05D0B

    Class III EUDAMED Active

  • MariSurgi Ref 50205S21D0B

    Class III EUDAMED Active

  • Kerecis Oral Ref K213904

    Class II FDA 510(k) Active

  • Kerecis Omega3 Wound Ref 50200S01B0B

    Class III EUDAMED Active

EUDAMED certificates2

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

EUDAMED certificates (2)

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

Related companies

Notified bodies

  • Notified body 0344

What Kerecis makes

Kerecis manufactures the Kerecis Oral, a device designed for oral cavity procedures, including laser-assisted tissue treatment and precision ablation.

The Kerecis Oral is classified as a Class II medical device and is listed under the FDA’s 510(k) pathway. The company is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Kerecis manufacture?

Kerecis specializes in devices for oral cavity procedures. Their primary product, the Kerecis Oral, is designed for laser-assisted tissue treatment and precision ablation within the oral cavity. This device is tailored for specific medical applications in dentistry or oral surgery.

Where is Kerecis based?

Kerecis is headquartered in the United States. The company’s location ensures it operates within the regulatory framework of the FDA, which governs medical device authorization in the US.

How are Kerecis’ devices classified under regulatory standards?

The Kerecis Oral is classified as a Class II medical device. This classification is determined by the FDA based on the device’s intended use and risk level, requiring premarket notification (510(k)) to demonstrate substantial equivalence to a legally marketed predicate device before commercialization.

Which regulatory registries or pathways list Kerecis’ devices?

Kerecis’ devices, such as the Kerecis Oral, are listed under the FDA’s 510(k) pathway. This pathway is a regulatory process where manufacturers submit premarket submissions to demonstrate that their device is at least as safe and effective as a legally marketed predicate device already on the market.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
Iceland
Address
2, Eyrargata, Isafjördur, Iceland
Phone
+354 419 8000
PRRC contact
Skuli Magnusson
EUDAMED SRN
IS-MF-000001365