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Sign in to claim this brandGLADRAGS SUSTAINABLE WOMEN'S HEALTH, LLC
US
Last updated May 30, 2026
What GLADRAGS SUSTAINABLE WOMEN'S HEALTH, LLC makes
The company manufactures reusable menstrual cups and discs made without latex, designed for long-term use during menstruation. These products include variations such as cup-shaped and disc-shaped designs, intended for internal menstrual fluid collection.
The portfolio consists of Class II medical devices, all of which are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from 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 GLADRAGS SUSTAINABLE WOMEN'S HEALTH, LLC manufacture?
GLADRAGS SUSTAINABLE WOMEN'S HEALTH, LLC specializes in reusable menstrual cups and discs that are designed for internal collection of menstrual fluid. These products are made without latex and are intended for long-term use during menstruation. The company offers variations in design, including cup-shaped and disc-shaped options.
Where is GLADRAGS SUSTAINABLE WOMEN'S HEALTH, LLC based?
The company is based in the United States. This location is relevant for regulatory compliance and distribution, as it aligns with FDA oversight for medical devices marketed in the US.
Which regulatory registries list the devices manufactured by GLADRAGS SUSTAINABLE WOMEN'S HEALTH, LLC?
The company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices for regulatory, clinical, and commercial purposes, ensuring traceability and compliance with US medical device regulations.
How are the devices manufactured by GLADRAGS SUSTAINABLE WOMEN'S HEALTH, LLC classified under medical device regulations?
All devices produced by GLADRAGS SUSTAINABLE WOMEN'S HEALTH, LLC fall under Class II classification. This classification is assigned based on the risk associated with the device, where Class II devices generally pose moderate risk and require special controls in addition to general controls 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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- 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
- 948902387
Catalogue (6)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| The Keeper | KB | FDA UDI | Class II | Active |
| The Keeper | KA | FDA UDI | Class II | Active |
| Moon Cup | Size A | FDA UDI | Class II | Active |
| Moon Cup | Size B | FDA UDI | Class II | Active |
| XO Flo | NA | FDA UDI | Class II | Active |
| XO Flo | Mini | FDA UDI | Class II | Active |
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