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Sign in to claim this brandMODERN HEALTH
US
Last updated May 24, 2026
What MODERN HEALTH makes
The company produces in-vitro diagnostics (IVDs) for fertility testing, including rapid immunochromatographic tests (ICT) for human chorionic gonadotropin (hCG) and luteinizing hormone (LH) in clinical and home-use formats, as well as pregnancy and ovulation test kits. It also manufactures a sexual lubricant designed for use during fertility treatments.
These devices are classified under FDA’s Class I and Class II regulatory categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The company 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 Modern Health manufacture?
Modern Health specializes in in-vitro diagnostics (IVDs) focused on fertility testing. This includes rapid immunochromatographic tests (ICT) for detecting human chorionic gonadotropin (hCG) and luteinizing hormone (LH), which are used for pregnancy and ovulation testing in both clinical and home-use settings. Additionally, the company produces a sexual lubricant intended for use during fertility treatments.
Where is Modern Health based, and what does that mean for its regulatory oversight?
Modern Health is based in the United States. Since it operates within the U.S., its devices are subject to FDA regulations, including classification under FDA’s categories and potential listing in the FDA’s Unique Device Identifier (UDI) database. The U.S. regulatory framework ensures these devices meet specific safety, performance, and labeling requirements before they are authorized for use.
Which regulatory registries or databases list Modern Health’s devices?
Modern Health’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their distribution and use, ensuring transparency and traceability for regulatory and clinical purposes.
How are Modern Health’s devices classified under FDA regulations?
Modern Health’s devices fall under FDA’s Class I and Class II classifications. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure their safety and effectiveness. The classification is determined based on factors like the device’s intended use, potential risks, and benefits.
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
- 115270384
Catalogue (10)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Modern Fertility Pregnancy Test | 1 | FDA UDI | Class II | Active |
| Modern Fertility Pregnancy Test | 1 | FDA UDI | Class II | Active |
| Modern Fertility Ovulation Test | 1 | FDA UDI | Class I | Active |
| Modern Fertility Ovulation Test | 1 | FDA UDI | Class I | Active |
| Modern Fertility Pregnancy Test | 1 | FDA UDI | Class II | Active |
| Modern Fertility Pregnancy Test | A | FDA UDI | Class II | Unknown |
| Modern Fertility Pregnancy Test | 1 | FDA UDI | Class II | Active |
| Modern Fertility Ovulation Test | A | FDA UDI | Class I | Unknown |
| Modern Fertility Lubricant | 1 | FDA UDI | Class II | Active |
| Modern Fertility Pregnancy Test | A | FDA UDI | Class II | Unknown |
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