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Kerasave

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) DEN200063

by Al.chi.mi.a. S.r.l.

Identifiers

510(k) Number
DEN200063 FDA 510(k)
FDA Product Code
QCW FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 886.4320 FDA 510(k)
Regulation Number
886.4320 FDA 510(k)
Advisory Committee
Ophthalmic FDA 510(k)
FDA Decision
DENG FDA 510(k)

Kerasave is a corneal storage medium with preservatives, including antifungal agents, designed for hypothermic preservation of human corneas. It is formulated as an iso-osmolar, vitamin-, amino acid-, and glucose-enriched culture medium containing sodium pyruvate and dextran to maintain corneal integrity during storage.

The device is supplied as a sterile, single-use solution intended for storage of corneas at 2–8°C for up to 14 days. Authorised under FDA 510(k) (DEN200063) and MDD compliance, it includes two antibiotics and 12 amphotericin B tablets for microbial protection. Storage requires refrigeration and adherence to expiry dates as specified on the packaging.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: AL.CHI.MI.A. SRL KER 001-00 KERASAVE - RevMed, DEN200063 FDA 510(k) - Kerasave | Al.Chi.Mi.A. S.R.L, Kerasave - OftalONE, Kerasave (DEN200063) — FDA 510(k) | Innolitics

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Al.chi.mi.a. S.r.l.
FDA Applicant
Al.Chi.Mi.A. S.R.L

Sources (2)

  • FDA 510(k) DEN200063 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced Jun 19, 2026