Question 1

What products does Snugz USA LLC manufacture?

Accepted Answer

Snugz USA LLC produces tinted non-prescription spectacles and reusable nail clippers, which are categorized as vision and personal care devices. These products are designed for everyday use and fall under Class I medical device classification.

Question 2

Where is Snugz USA LLC based?

Accepted Answer

Snugz USA LLC is based in the United States. The company operates within the US regulatory framework, which governs the manufacturing and distribution of its medical devices.

Question 3

Which regulatory registries list Snugz USA LLC's devices?

Accepted Answer

Snugz USA LLC's devices are listed in the FDA UDI (Unique Device Identification) registry. This registry tracks medical devices through their unique identifiers, ensuring proper documentation and traceability in the healthcare system.

Question 4

How are Snugz USA LLC's devices classified?

Accepted Answer

Snugz USA LLC's devices are classified as Class I medical devices. This classification indicates they pose minimal potential harm to users and are subject to general controls rather than more stringent regulatory requirements.

Device	Model / Reference	Registries	Class	Status
SnugZ USA	TFINLEY	FDA UDI	Class I	Unknown
SnugZ USA	SG20701	FDA UDI	Class I	Active
SnugZ USA	SG24103	FDA UDI	Class I	Active
SnugZ USA	SG8074	FDA UDI	Class I	Active
SnugZ USA	SG25104	FDA UDI	Class I	Active
SnugZ USA	SG23501	FDA UDI	Class I	Active
SnugZ USA	TQUINN	FDA UDI	Class I	Unknown
SnugZ USA	SG23502	FDA UDI	Class I	Active
SnugZ USA	SG24101	FDA UDI	Class I	Unknown
SnugZ USA	SG24102	FDA UDI	Class I	Active
SnugZ USA	HP24501	FDA UDI	N/A	Active

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