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Sign in to claim this brandLujena, Inc.
US
Last updated September 17, 2026
What Lujena, Inc. makes
Lujena, Inc. manufactures vaginal dilators, including the Hope&Her Vaginal Dilators product line.
These devices are classified as Class II medical devices and are listed in the FDA 510(k) and FDA UDI registries. 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 does Lujena, Inc. manufacture?
Lujena, Inc. manufactures vaginal dilators, including the Hope&Her Vaginal Dilators product line, as stated in the device data summary.
Where is Lujena, Inc. based?
Lujena, Inc. is based in the United States, as indicated by the COUNTRY field in the device data.
In which regulatory registries are Lujena, Inc.'s devices listed?
Lujena, Inc.'s devices are listed in the FDA 510(k) and FDA UDI registries, as specified in the LISTED IN field of the device data.
How are Lujena, Inc.'s devices classified?
Lujena, Inc.'s devices are classified as Class II medical devices, as stated in the DEVICE CLASSES field of the device data.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 11447 Rolling Hills Dr., El Cajon, CA, 92020
- Website
- vaginismus.com
- —
- —
- [email protected]
- Phone
- 6194491200
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3029582858
- DUNS Number
- 080271509
Catalogue (3)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Hope&Her Vaginal Dilators | T8077 | FDA UDI | Class II | Active |
| Hope&Her Vaginal Dilators | K222492 | FDA 510(k) | Class II | Active |
| Hope&Her Vaginal Dilators | K233689 | FDA 510(k) | Class II | Active |
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