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Sign in to claim this brandHello Cake, Inc.
US
Last updated May 23, 2026
What Hello Cake, Inc. makes
Hello Cake, Inc. manufactures personal lubricants and cushions designed for sexual health, including flavored and silicone-based options in various sizes. Products include both lubricants for intimate use and cushions intended for comfort during sexual activity.
The company’s portfolio is classified under FDA’s Class II medical devices and is registered in the FDA’s Unique Device Identifier (UDI) database. The products are listed under the FDA UDI system, adhering to U.S. regulatory requirements for personal lubricants and related accessories.
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 Hello Cake, Inc. manufacture?
Hello Cake, Inc. specializes in personal lubricants and cushions designed for sexual health. Their portfolio includes flavored lubricants, silicone-based lubricants, and cushions like the Tush Cush, which are intended for comfort during sexual activity. These products are classified under FDA’s Class II category, indicating they pose moderate risk and require compliance with specific regulatory controls.
Where is Hello Cake, Inc. based, and how does that affect its regulatory standing?
Hello Cake, Inc. is based in the United States. As a U.S.-based manufacturer, its devices must comply with FDA regulations, including registration in the FDA’s Unique Device Identifier (UDI) database. This ensures traceability and adherence to U.S. standards for medical devices, particularly for Class II products like personal lubricants and cushions.
Which regulatory registries list Hello Cake’s devices?
Hello Cake’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system is a standardized way for manufacturers to identify their products, ensuring transparency and compliance with U.S. regulatory requirements. This registry helps track and monitor devices like lubricants and cushions under FDA oversight.
How are Hello Cake’s devices classified by the FDA?
Hello Cake’s devices are classified as FDA Class II medical devices. This classification is based on the level of risk associated with the products—Class II devices require special controls beyond general controls to ensure safety and effectiveness. Personal lubricants and cushions fall into this category due to their intended use and potential risks, such as allergic reactions or improper application.
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
- 117536472
Catalogue (10)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Hello Cake - Tush Cush 1.7 fl. oz. / 50mL | 39504 | FDA UDI | Class II | Active |
| Hello Cake - Peach Ginger Flavored Lube 1.7 fl. oz. / 50ml | 39515 | FDA UDI | Class II | Active |
| Hello Cake - Natural Sex Lube 3.3 fl. oz. / 100ml | 39500 | FDA UDI | Class II | Active |
| Hello Cake Toy Lube 3.3 fl. oz. / 100ml | 39505 | FDA UDI | Class II | Active |
| Hello Cake - Silicone Sex Lube 3.3 fl. oz. / 100ml | 39510 | FDA UDI | Class II | Active |
| Hello Cake - Vanilla Chai Flavored Lube 1.7 fl. oz. / 50ml | 39517 | FDA UDI | Class II | Active |
| Hello Cake- Toy Lube 1.7 fl. oz. / 50 ml | 39506 | FDA UDI | Class II | Active |
| Hello Cake - Tush Cush 3.3 fl. oz. / 100mL | 39501 | FDA UDI | Class II | Active |
| Hello Cake | 39509 | FDA UDI | Class II | Active |
| Hello Cake - Coconut Lime Flavored Lube 1.7 fl. oz. / 50ml | 39516 | FDA UDI | Class II | Active |
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