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Areza Medical

FDA UDI

Class U (US FDA UDI)

by Advanced Medical Associates, Llc

Identity

Trade Name
Areza Medical FDA UDI
Generic Name
Exudate-absorbent dressing, hydrophilic-gel, antimicrobial FDA UDI
Device Name
Areza Antibacterial Alginate with Silver is made of natural alginate fibers derived from seaweed through a series of special processes. Designed to be highly absorbent, the dressing rapidly absorbs exudates and forms a gel-like covering over the wound, maintaining a moist environment ideal for wound healing. The gel-like surface also keeps the dressing from adhering to the wound, so it is a painless removal. Areza Antibacterial Alginate with Silver can restrain the bacteria growing and reduce further bacterial infection. It has been tested in vitro and found to be effective against bacteria such as: Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes, Escherichia coli, Pseudomonsa aeruginosa, Klebsiella pneumoniae. FDA UDI
Model / Reference
57258 FDA UDI
Description
Areza Antibacterial Alginate with Silver is made of natural alginate fibers derived from seaweed through a series of special processes. Designed to be highly absorbent, the dressing rapidly absorbs exudates and forms a gel-like covering over the wound, maintaining a moist environment ideal for wound healing. The gel-like surface also keeps the dressing from adhering to the wound, so it is a painless removal. Areza Antibacterial Alginate with Silver can restrain the bacteria growing and reduce further bacterial infection. It has been tested in vitro and found to be effective against bacteria such as: Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes, Escherichia coli, Pseudomonsa aeruginosa, Klebsiella pneumoniae. FDA UDI

Identifiers

Catalog Number
57258 FDA UDI
Primary DI / UDI-DI
00850021481117 FDA UDI
FDA Product Code
FRO FDA UDI
GMDN Term
Exudate-absorbent dressing, hydrophilic-gel, antimicrobial FDA UDI

Classification

Device Class
U FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Exudate-absorbent dressing, hydrophilic-gel, antimicrobial

Areza Medical by Advanced Medical Associates, Llc — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Exudate-absorbent dressing, hydrophilic-gel, antimicrobial.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Advanced Medical Associates, Llc

Sources (1)

  • FDA UDI ebca5259-760f-4309-bd99-b3f63d5c5a16 36 fields · synced May 31, 2026