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Sign in to claim this brandRB Health (us) LLC
US
Last updated May 29, 2026
What RB Health (us) LLC makes
RB Health (US) LLC manufactures basic male condoms made from Hevea latex and synthetic polymers, including flavored and textured variants, as well as penile rings and vaginal lubricants. Their portfolio includes standard-fit, wide-fit, and close-fit condoms, alongside flavored and pleasure-focused products.
These devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) and UDI registries. 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 RB Health (US) LLC manufacture?
RB Health (US) LLC specializes in reproductive health devices, primarily focusing on basic male condoms made from Hevea latex and synthetic polymers. Their portfolio includes standard, flavored, and textured variants like cherry-flavored condoms, as well as penile rings and vaginal lubricants. These products are designed for contraception, barrier protection, and sexual health enhancement.
Where is RB Health (US) LLC based, and what does that mean for their regulatory oversight?
RB Health (US) LLC is based in the United States, which means their devices fall under FDA jurisdiction. Since their products are classified as Class II devices, they must comply with FDA regulations, including premarket notifications (510(k)) and Unique Device Identification (UDI) requirements. The U.S. regulatory framework ensures these products meet safety, effectiveness, and performance standards before entering the market.
Which regulatory registries list RB Health (US) LLC’s devices, and why does that matter?
RB Health (US) LLC’s devices are listed in the FDA’s 510(k) and UDI registries. The 510(k) registry documents premarket submissions proving their devices are substantially equivalent to legally marketed predicates, while the UDI system ensures traceability and transparency in the supply chain. These listings help healthcare providers, regulators, and patients verify the device’s authorized status and compliance with U.S. regulations.
How are RB Health (US) LLC’s devices classified by the FDA, and what does that classification imply?
RB Health (US) LLC’s devices are classified as Class II by the FDA, which means they pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness. This classification typically involves mandatory registration, listing, and compliance with FDA-recognized standards or post-market surveillance requirements. Class II devices require premarket notification (510(k)) to demonstrate equivalence to existing approved devices.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- xxx.xxx
- —
- —
- [email protected]
- Phone
- +1(800)756-5488
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 081049410
Catalogue (175)
Page 2 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| KY Liquid Lubricant | Personal Lubricant | FDA UDI | Class II | Unknown |
| DUREX Tropical Strawberry | Condom | FDA UDI | Class II | Active |
| Durex Intense Ultra Lube | 00302340996020 | FDA UDI | Class II | Active |
| KY Intense Pleasure Gel | Personal Lubricant | FDA UDI | Class II | Unknown |
| DUREX Extra Sensitive Condom | Condom | FDA UDI | Class II | Unknown |
| KY Liquibeads Vaginal Moisturizer | Personal Lubricant | FDA UDI | Class II | Active |
| KY Warming Jelly Lubricant | Personal Lubricant | FDA UDI | Class II | Active |
| KY Warming Liquid Lubricant | 00067981994155 | FDA UDI | Class II | Active |
| DUREX Intense Sensation Condom | 00302340096584 | FDA UDI | Class II | Active |
| KY® True Feel | Personal Lubricant | FDA UDI | Class II | Unknown |
| KY Natural Feeling with Botanical Essence Lubricant & Massage Gel | Personal Lubricant | FDA UDI | Class II | Active |
| DUREX XXL Condom | Condom | FDA UDI | Class II | Unknown |
| DUREX RealFeel Non-Latex Condom | Condom | FDA UDI | Class II | Unknown |
| KY Personal Lubricant Jelly | Personal Lubricant | FDA UDI | Class II | Active |
| DUREX Performax Intense Condom | Condom | FDA UDI | Class II | Unknown |
| DUREX Extra Sensitive Condom | Condom | FDA UDI | Class II | Active |
| Durex PleasureMax Condom | Condom | FDA UDI | Class II | Active |
| DUREX Play Vibrations Ring | Condom | FDA UDI | Class II | Active |
| KY Love Passion Couples Lubricant | Personal Lubricant | FDA UDI | Class II | Active |
| DUREX® Extra Sensitive Wide Fit - Condom | Condom | FDA UDI | Class II | Active |
| DUREX Extra Sensitive Condom | 00302340995542 | FDA UDI | Class II | Active |
| DUREX Extra Sensitive Thin Close Fit Condom | 00302340876506 | FDA UDI | Class II | Active |
| Durex Extra Sensitive Close Fit Condom | Condom | FDA UDI | Class II | Unknown |
| KY Touch 2-in-1 Massage Creme & Pleasure Gel | Personal Lubricant | FDA UDI | Class II | Active |
| DUREX Tropical Banana | Condom | FDA UDI | Class II | Active |
| KY Liquid Lubricant | Personal Lubricant | FDA UDI | Class II | Unknown |
| DUREX Extra Sensitive Condom | Condom | FDA UDI | Class II | Unknown |
| Durex Intense XL | 00302340996006 | FDA UDI | Class II | Active |
| KY Natural Feeling Moisturizing Lubricant with Hyaluronic Acid | Personal Lubricant | FDA UDI | Class II | Unknown |
| DUREX Invisible Condom | Condom | FDA UDI | Class II | Active |
| DUREX Tropical Orange | Condom | FDA UDI | Class II | Active |
| DUREX Air Close Fit Condom | 00302340876452 | FDA UDI | Class II | Active |
| Durex Intense XL | 00302340995825 | FDA UDI | Class II | Active |
| K-Y® Hydrablend | 00067981993783 | FDA UDI | Class II | Active |
| DUREX Pleasure Pack Condom | Condom | FDA UDI | Class II | Active |
| QUEEN V p.s. I Lube You Intimate Lube | Personal Lubricant | FDA UDI | Class II | Active |
| KY Touch 2-in-1 Massage Creme & Pleasure Gel | Personal Lubricant | FDA UDI | Class II | Active |
| KY Intense Pleasure Gel | Personal Lubricant | FDA UDI | Class II | Active |
| DUREX Massage & Play - Soothing Touch 2 in 1 Lubricant - Aloe Vera | Personal Lubricant | FDA UDI | Class II | Active |
| DUREX Tropical Condoms | 00302340090001 | FDA UDI | Class II | Active |
| DUREX Tropical Apple | Condom | FDA UDI | Class II | Active |
| KY True Feel Premium Silicone Lubricant | Personal Lubricant | FDA UDI | Class II | Unknown |
| DUREX Real Feel Non-Latex Condom | 00302340908054 | FDA UDI | Class II | Active |
| DUREX Air Close Fit Condom | 00302340876438 | FDA UDI | Class II | Active |
| KY Extra Lubricated Condoms | Condom | FDA UDI | Class II | Active |
| K-Y® Hydrablend | 00067981993790 | FDA UDI | Class II | Active |
| KY Extra Lubricated Condoms | Condom | FDA UDI | Class II | Active |
| DUREX Extra Sensitive Stimulating Condom | Condom | FDA UDI | Class II | Active |
| KY Extra Lubricated Condoms | Condom | FDA UDI | Class II | Active |
| DUREX® Air Regular Fit; DUREX® Air | 00067981087970 | FDA UDI | Class II | Active |
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