FDA.reportPublic FDA data

AL.CHI.MI.A

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30044718193004471819AL.CHI.MI.A. SRL1N2026-01-01VIALE AUSTRIA 14 PONTE S. NICOLO Padova IT 35020

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
08021118000593EUSOL-C - EUSOL-C is a low salt, vitamin, amino acid, and glucose-enriched iso-osmolar corneal culture balanced medium with sodium piruvate as an ATP precursor and dextran as a deturgescent agent. It is supplemented with 143 ug/ml gentamicin sulfate. It has sodium bicarbonate and Hepes buffers to maintain pH in the range of 7.2 – 7.6 and Phenol red as a pH indicator. EUSOL-C is for storage of donor corneas at 2°C – 8°C for up to 14 days.It provides basic nutrients for cell maintenance and prevents tissue swelling preserving corneal thickness.+390498962074info@alchimiasrl.com
08021118001408KERASAVE - Kerasave is a low salt, vitamin, amino acid, and glucose-enriched iso-osmolar corneal culture balanced medium with sodium pyruvate as an ATP precursor and dextran as a deturgescent agent. It is supplemented with 100 ug/ml gentamicin sulfate and 200 ug/ml streptomycin sulfate, and a tablet to be dissolved in the medium prior to use, corresponding to 2.5 ug/ml of amphotericin B. It has sodium bicarbonate and Hepes buffers to maintain pH in the range of 7.2 – 7.6 and Phenol red as a pH indicator.It provides basic nutrients for cell maintenance.+390498962074info@alchimiasrl.com
08021118001552XTRA4 - XTRA4 is a sterile hypothermic corneal storage medium intended for human corneal storage between 2 and 8°C for up to 14 days. It is designed as a single use 20 mL solution in glass vials. XTRA4 is intended to be used only by physicians or highly skilled personnel such as eye bank operators.+390498962074info@alchimiasrl.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
220211908298673K251320XTRA4LYX2025-09-11
220211495146266K162013Eusol-CLYX2016-09-15
220211789744870DEN200063KerasaveQCW2022-05-02
220211948468799
220211311895252

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LYX32025-09-11
QCW12022-05-02

PMN#

Eusol-C

2016-09-15

AL.CHI.MI.A. S.r.l.

GUDID#

EUSOL-C - EUSOL-C is a low salt, vitamin, amino acid, and glucose-enriched iso-osmolar corneal culture balanced medium with sodium piruvate as an ATP precursor and dextran as a deturgescent agent. It is supplemented with 143 ug/ml gentamicin sulfate. It has sodium bicarbonate and Hepes buffers to maintain pH in the range of 7.2 – 7.6 and Phenol red as a pH indicator. EUSOL-C is for storage of donor corneas at 2°C – 8°C for up to 14 days.It provides basic nutrients for cell maintenance and prevents tissue swelling preserving corneal thickness.

AL.CHI.MI.A. SRL

2022-12-22

KERASAVE - Kerasave is a low salt, vitamin, amino acid, and glucose-enriched iso-osmolar corneal culture balanced medium with sodium pyruvate as an ATP precursor and dextran as a deturgescent agent. It is supplemented with 100 ug/ml gentamicin sulfate and 200 ug/ml streptomycin sulfate, and a tablet to be dissolved in the medium prior to use, corresponding to 2.5 ug/ml of amphotericin B. It has sodium bicarbonate and Hepes buffers to maintain pH in the range of 7.2 – 7.6 and Phenol red as a pH indicator.It provides basic nutrients for cell maintenance.

AL.CHI.MI.A. SRL

2022-12-05