Question 1

What types of medical devices does EuroProSan SpA manufacture?

Accepted Answer

EuroProSan SpA specializes in single-use incontinence products, including incontinence pants, adult nappies, and non-antimicrobial absorbent underpads. These devices are designed for temporary or disposable use in managing urinary incontinence or absorbing fluids in bed or chair settings.

Question 2

Where is EuroProSan SpA based?

Accepted Answer

EuroProSan SpA is based in the United States. The company’s location is relevant for understanding regulatory compliance and market focus, particularly in the U.S. healthcare system.

Question 3

Which regulatory registries list EuroProSan SpA’s devices?

Accepted Answer

EuroProSan SpA’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and compliance with U.S. medical device regulations, helping healthcare providers and regulators identify and verify the products.

Question 4

How are EuroProSan SpA’s devices classified under medical device regulations?

Accepted Answer

EuroProSan SpA’s devices fall under Class I classification, which is the lowest risk category for medical devices. This classification applies to products like single-use incontinence pants and absorbent underpads, where the risk to patients is minimal and regulatory oversight is streamlined.

Device	Model / Reference	Registries	Class	Status
Flufsan	FLUFSAN SOFT XLARGE SUPER NIGHT	FDA UDI	Class I	Active
Flufsan	LADY SUPERPLUS for serious incontinence	FDA UDI	Class I	Active
Flufsan	FLUFSAN SOFT SMALL DAY & NIGHT	FDA UDI	Class I	Active
Flufsan	ADULT PANTS EXTRALARGE SUPER NIGHT	FDA UDI	Class I	Active
Flufsan	FLUFSAN SOFT LARGE NIGHT	FDA UDI	Class I	Active
Flufsan	Flufsan LADY DISCREET PANTS LARGE	FDA UDI	Class I	Active
Flufsan	Flufsan 60X60	FDA UDI	Class I	Active
Flufsan	FLUFSAN SOFT MEDIUM SUPER NIGHT	FDA UDI	Class I	Active
Flufsan	FLUFSAN LADY PANTS MEDIUM	FDA UDI	Class I	Active
Flufsan	FLUFSAN SOFT XLARGE NIGHT	FDA UDI	Class I	Active
Flufsan	ADULT PANTS EXTRA LARGE MAXI	FDA UDI	Class I	Active
Flufsan	MINIPLUS 10,5 x 37 cm	FDA UDI	Class I	Active
Flufsan	Flufsan 40X60	FDA UDI	Class I	Active
Flufsan	LADY NORMAL for light incontinence	FDA UDI	Class I	Active
Flufsan	FLUFSAN SOFT XLARGE DAY	FDA UDI	Class I	Active
Flufsan	SUPER 20x60 cm with barrier	FDA UDI	Class I	Active
Flufsan	FLUFSAN SOFT LARGE DAY	FDA UDI	Class I	Active
Flufsan	ADULT PANTS LARGE EXTRA DAY	FDA UDI	Class I	Active
Flufsan	LADY SUPER for serious incontinence	FDA UDI	Class I	Active
Flufsan	ADULT PANTS XXL SUPER NIGHT	FDA UDI	Class I	Active
Flufsan	LADY EXTRA for medium incontinence	FDA UDI	Class I	Active
Flufsan	FLUFSAN SOFT MEDIUM NIGHT	FDA UDI	Class I	Active
Flufsan	FLUFSAN MAN LIV 2	FDA UDI	Class I	Active
Flufsan	FLUFSAN SOFT LARGE SUPER NIGHT	FDA UDI	Class I	Active
Flufsan	ADULT PANTS LARGE MAXI SUPERNIGHT	FDA UDI	Class I	Active
Flufsan	Flufsan 60X90	FDA UDI	Class I	Active
Flufsan	FLUFSAN MAN LIV 1	FDA UDI	Class I	Active
Flufsan	Flufsan 60x90 COMPACT	FDA UDI	Class I	Active
Flufsan	SUPER 20x60 cm	FDA UDI	Class I	Active
Flufsan	FLUFSAN SOFT MEDIUM DAY	FDA UDI	Class I	Active
Flufsan	ADULT PANTS EXTRA LARGE EXTRA DAY	FDA UDI	Class I	Active
Flufsan	Flufsan 80X180 with wings	FDA UDI	Class I	Active
Flufsan	ADULT PANTS LARGE SUPER NIGHT	FDA UDI	Class I	Active

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