AL.CHI.MI.A. SRL

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3004471819	3004471819	AL.CHI.MI.A. SRL	1	N	2026-01-01	VIALE 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 GUDID	Product	Phone	Email
08021118000593	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.	+390498962074	info@alchimiasrl.com
08021118001408	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.	+390498962074	info@alchimiasrl.com
08021118001552	XTRA4 - 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.	+390498962074	info@alchimiasrl.com

alchimiasrl.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
22021	1908298673	K251320	XTRA4	LYX	2025-09-11
22021	1495146266	K162013	Eusol-C	LYX	2016-09-15
22021	1789744870	DEN200063	Kerasave	QCW	2022-05-02
22021	1948468799
22021	1311895252

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
LYX	3	2025-09-11
QCW	1	2022-05-02

GUDID#

XTRA4 - 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.
AL.CHI.MI.A. SRL
2025-10-13
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