Question 1

What types of medical devices does Quadralene Limited manufacture?

Accepted Answer

Quadralene Limited specializes in medical device cleaning agents and instrument rinsing solutions. Their portfolio includes enzymatic cleaners (like Xen Enzymatic and Xen Enzymatic+), universal disinfectants (such as Xen Universal and Xen Universal+), and specialized rinsing agents (for example, Xen Rinse). These products are designed specifically for medical device reprocessing to ensure proper decontamination in healthcare environments.

Question 2

Where is Quadralene Limited based?

Accepted Answer

Quadralene Limited is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework and operational reach, particularly in markets where U.S.-based manufacturers are subject to specific compliance requirements.

Question 3

How are Quadralene Limited’s devices classified under medical device regulations?

Accepted Answer

Quadralene Limited’s devices are classified as Class I medical devices. This classification is typically assigned to low-risk products, such as cleaning agents and rinsing solutions, where the risk to patients is minimal. Class I devices often require less stringent regulatory oversight compared to higher-risk categories, though compliance with manufacturing and labeling standards remains mandatory.

Question 4

Are Quadralene Limited’s devices listed in any regulatory registries?

Accepted Answer

Yes, Quadralene Limited’s devices are included in the FDA’s Unique Device Identifier (UDI) database. The UDI system ensures traceability and transparency in the medical device supply chain, allowing healthcare providers, regulators, and other stakeholders to identify and verify specific products. Listing in this database is a requirement for Class I devices in the U.S., supporting post-market surveillance and compliance tracking.

Device	Model / Reference	Registries	Class	Status
Xen Universal 5G	XV1610/19NA	FDA UDI	Class I	Active
Xen Sanizyme+ 15G	XV1SZM/57NA	FDA UDI	Class I	Active
Xen Enzymatic 5L	XV1807/5NA	FDA UDI	Class I	Active
Xen Xcelerate+	XV1830/500NA	FDA UDI	Class I	Active
Xen Rinse 5G	XV1479/19NA	FDA UDI	Class I	Active
Xen Universal+ 5G	XV1825/19NA	FDA UDI	Class I	Active
Xen Neutral+ 5G	XV1827/19NA	FDA UDI	Class I	Active
Xen Enzymatic+ 15G	XV1755/57NA	FDA UDI	Class I	Active
Xen Enzymatic 15G	XV1807/57NA	FDA UDI	Class I	Active
Xen Neutral+ 15G	XV1827/57NA	FDA UDI	Class I	Active
Xen Sanizyme+ 5G	XV1SZM/19NA	FDA UDI	Class I	Active
Xen Universal+ 15G	XV1825/57NA	FDA UDI	Class I	Active
Xen Universal+ 5L	XV1825/5NA	FDA UDI	Class I	Active
Xen Universal 15G	XV1610/57NA	FDA UDI	Class I	Active
Xen Neutral 5G	XV1826/19NA	FDA UDI	Class I	Active
Xen Enzymatic+ 5G	XV1755/19NA	FDA UDI	Class I	Active
Xen Xcelerate+ Lumen	XV1LMN/500NA	FDA UDI	Class I	Active
Xen Neutral 5L	XV1826/5NA	FDA UDI	Class I	Active
Xen Enzymatic 5G	XV1807/19NA	FDA UDI	Class I	Active
Xen Neutral+ 5L	XV1827/5NA	FDA UDI	Class I	Active
Xen Universal 5L	XV1610/5NA	FDA UDI	Class I	Active
Xen Sanizyme+ 5L	XV1SZM/5NA	FDA UDI	Class I	Active
Xen Neutral 15G	XV1826/57NA	FDA UDI	Class I	Active
Xen Rinse 5L	XV1479/5NA	FDA UDI	Class I	Active
Xen Enzymatic+ 5L	XV1755/5NA	FDA UDI	Class I	Active
Xen Xcelerate	XV1509/TNA	FDA UDI	Class I	Active
Xen Rinse 15G	XV1479/57NA	FDA UDI	Class I	Active
Xen QuadX 2x5L	XV1QDX/2X5NA	FDA UDI	Class I	Active

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