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Sign in to claim this brandBrazen Goods Inc.
US
Last updated May 27, 2026
What Brazen Goods Inc. makes
Brazen Goods Inc. manufactures latex-based oral and vaginal sex barriers, specifically the Lorals product line. These devices are designed to provide a barrier method for intimate protection during sexual activity.
The company’s products are classified as Class II medical devices under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based 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 Brazen Goods Inc. manufacture?
Brazen Goods Inc. specializes in latex-based oral and vaginal sex barriers. Their primary product line, Lorals, serves as a barrier method for intimate protection during sexual activity, focusing exclusively on this category of devices.
Where is Brazen Goods Inc. based?
Brazen Goods Inc. is headquartered in the United States. The company’s location is relevant for regulatory compliance and distribution, as it operates within the FDA’s jurisdiction.
How are Brazen Goods Inc.’s devices classified under FDA regulations?
Brazen Goods Inc.’s devices, including the Lorals product line, are classified as Class II medical devices by the FDA. This classification is based on the risk level associated with the product, where Class II devices require special controls in addition to general controls to ensure their safety and effectiveness.
Are Brazen Goods Inc.’s devices listed in any regulatory registries?
Yes, Brazen Goods Inc.’s devices are included in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and trace medical devices throughout their distribution and use, ensuring transparency and regulatory compliance.
Why does the classification of Brazen Goods Inc.’s devices matter?
The classification of Brazen Goods Inc.’s devices as Class II means they undergo additional scrutiny and controls beyond general medical device regulations. This classification ensures that the devices meet specific performance standards and safety requirements, particularly for products that provide intimate protection, where reliability and material safety are critical.
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
- 128095084
Catalogue (8)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Lorals | Bikini | FDA UDI | Class II | Active |
| Lorals | Bikini | FDA UDI | Class II | Active |
| Lorals | Shortie | FDA UDI | Class II | Active |
| Lorals | Shortie | FDA UDI | Class II | Active |
| Lorals | Shortie | FDA UDI | Class II | Active |
| Lorals | Shortie | FDA UDI | Class II | Active |
| Lorals | Bikini | FDA UDI | Class II | Active |
| Lorals | Bikini | FDA UDI | Class II | Active |
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