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US
Last updated May 24, 2026
What RAEL INC makes
Rael Inc manufactures unscented menstrual tampons, including organic cotton varieties with regular absorbency. The product line includes standard tampons under the Rael brand, designed for internal menstrual protection.
The company’s tampons are classified as Class II medical devices in the US, authorised via 510(k) premarket notifications and listed in the FDA’s Unique Device Identifier (UDI) database. The products are regulated under US medical device laws.
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 Rael Inc manufacture?
Rael Inc specializes in menstrual tampons, specifically unscented varieties. Their product line includes standard tampons under the Rael brand, as well as organic cotton tampons with regular absorbency. These devices are designed for internal menstrual protection and fall under the category of feminine hygiene products regulated as medical devices.
Where is Rael Inc based, and how does that affect its regulatory standing?
Rael Inc is based in the United States, which means its devices are subject to US medical device regulations. Since the company’s products are authorised under US laws, they are classified and listed according to the FDA’s framework, including requirements like 510(k) premarket notifications and UDI registration.
Which regulatory registries or databases list Rael Inc’s devices?
Rael Inc’s devices are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with US regulatory requirements. Additionally, their products are authorised through 510(k) premarket notifications, which are part of the FDA’s regulatory process for Class II medical devices.
How are Rael Inc’s menstrual tampons classified under US regulations?
Rael Inc’s menstrual tampons are classified as Class II medical devices in the US. This classification requires compliance with specific regulatory controls, including premarket notifications (510(k)) to demonstrate safety and effectiveness before they can be marketed. Class II devices are considered to have an acceptable risk/benefit profile but still require additional regulatory oversight.
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
- 087378348
Catalogue (14)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Rael | Non-Applicator Super | FDA UDI | Class II | Unknown |
| Rael | Cardboard Applicator Super - Bulk | FDA UDI | Class II | Unknown |
| Rael | Cardboard Applicator Regular | FDA UDI | Class II | Unknown |
| Rael | RAEL-CTR18-V30-01 | FDA UDI | Class II | Active |
| Rael | Cardboard Applicator Super | FDA UDI | Class II | Unknown |
| Rael | RAEL-CTS18-V30-01 | FDA UDI | Class II | Active |
| Rael | RAEL-TPA-SP-V20-01 | FDA UDI | Class II | Active |
| Rael | RAEL-TR-V30-01 | FDA UDI | Class II | Active |
| Rael | Cardboard Applicator Regular - Bulk | FDA UDI | Class II | Unknown |
| Rael | RAEL-TS-V30-01 | FDA UDI | Class II | Active |
| Rael | RAEL-TPA-RG-V20-01 | FDA UDI | Class II | Active |
| Rael | Non Applicator Regular | FDA UDI | Class II | Unknown |
| Rael Organic Cotton Tampons: Regular Absorbancy | RAEL-TP-RG-01 | FDA UDI | Class II | Active |
| Rael Tampon | K182814 | FDA 510(k) | Class II | Active |
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