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Cycle, LLC

US

Last updated May 30, 2026

What Cycle, LLC makes

Cycle, LLC manufactures menstrual tampons, including scented and unscented varieties, as well as a reusable applicator designed for use with their tampons. Their product line focuses on disposable and reusable options for menstrual hygiene.

The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) and UDI registries. Their products are intended for use in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Cycle, LLC manufacture?

Cycle, LLC specializes in menstrual hygiene products, specifically disposable tampons (both scented and unscented) and a reusable tampon applicator. These devices are designed to provide menstrual care options for users in the United States.

Where is Cycle, LLC based, and where are their devices intended for use?

Cycle, LLC is based in the United States. Their devices are intended for use within the U.S. market, where they are subject to FDA regulations.

Which regulatory registries list Cycle, LLC’s devices?

Cycle, LLC’s devices are listed in the FDA’s 510(k) premarket notification registry and the FDA’s Unique Device Identifier (UDI) system. These registries help track and identify their Class II medical devices for compliance and transparency purposes.

How are Cycle, LLC’s devices classified under FDA regulations?

Cycle, LLC’s menstrual tampons and applicators fall under Class II classification by the FDA. This classification is typically assigned to devices that pose moderate risk and require special controls—such as performance standards or post-market surveillance—to ensure safety and effectiveness.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US
Address
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Website
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LinkedIn
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Facebook
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Email
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Phone
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PRRC Contact
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EUDAMED SRN
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FDA FEI Number
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DUNS Number
111488323

Catalogue (2)

DeviceModel / ReferenceRegistriesClassStatus
Every Cycle 7000
FDA UDI
Class IIActive
Every Cycle Reusable Tampon Applicator K211519
FDA 510(k)
Class IIActive

Related Companies

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