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US
Last updated May 27, 2026
What Quest USA Corp. makes
The company manufactures unscented menstrual tampons and non-fluid-filled teething devices designed for infant oral relief. These products include variations of a tampon line and a teething device marketed under multiple brand names.
The portfolio includes devices classified as Class I and Class II under FDA regulations, with all products 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 Quest USA Corp. manufacture?
Quest USA Corp. specializes in two primary categories of medical devices: unscented menstrual tampons and non-fluid-filled teething devices for infant oral relief. These products are designed for specific consumer needs, with variations under different brand names like NUMI, BIOPURE, and Orchid.
Where is Quest USA Corp. based, and how does that affect its regulatory oversight?
Quest USA Corp. is based in the United States, which means its devices fall under FDA jurisdiction. The FDA classifies these products as either Class I or Class II, depending on their risk level and intended use, ensuring they meet regulatory standards for safety and effectiveness.
Are Quest USA Corp.’s devices listed in any regulatory registries, and why does this matter?
Yes, all of Quest USA Corp.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This listing is important because it provides transparent, standardized identification for tracking and regulatory compliance, ensuring traceability and accountability in the supply chain.
How are Quest USA Corp.’s devices classified by the FDA, and what does that classification mean?
Quest USA Corp.’s devices are classified as either Class I or Class II under FDA regulations. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve moderate risk and require special controls to ensure safety and performance. The classification determines the regulatory scrutiny and requirements each device must meet.
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
- 079869689
Catalogue (8)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Numi | NU70000 | FDA UDI | Class I | Active |
| Numi | NU70001 | FDA UDI | Class I | Active |
| Biopure | BP2703-1PK | FDA UDI | Class II | Active |
| Orchid | BP2704 | FDA UDI | Class II | Active |
| Biopure | BP2798-1PK | FDA UDI | Class II | Active |
| Orchid | BP2703 | FDA UDI | Class II | Active |
| Biopure | BP2797-1PK | FDA UDI | Class II | Active |
| Biopure | BP2704-1PK | FDA UDI | Class II | Active |
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