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US
Last updated May 24, 2026
What SURETEX LIMITED - BRANCH makes
Suretex Limited produces basic male condoms made from both Hevea latex and synthetic polymers, as well as sexual lubricants. Their portfolio includes multiple condom variants under the brand names Lifestyles and Skyn, designed for general contraceptive and barrier protection use.
These devices are classified as Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates as a branch 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 Suretex Limited manufacture?
Suretex Limited manufactures basic male condoms, including those made from Hevea latex and synthetic polymers, as well as sexual lubricants. These products are primarily designed for contraceptive and barrier protection purposes.
Where is Suretex Limited based, and how does that affect its devices?
Suretex Limited operates as a branch in the United States. This means their devices are subject to U.S. regulatory requirements, including classification and listing in the FDA’s Unique Device Identifier (UDI) database.
Which regulatory registries list Suretex Limited’s devices?
Suretex Limited’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify their products under U.S. regulatory oversight.
How are Suretex Limited’s devices classified under FDA regulations?
Suretex Limited’s devices, including their condoms and lubricants, are classified as Class II under FDA regulations. This classification typically indicates moderate risk, requiring special controls beyond general controls to ensure safety and effectiveness.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- lifestyles.com
- —
- —
- [email protected]
- Phone
- 8482293224
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 672044515
Catalogue (397)
Page 6 of 8| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Skyn | 08859798100056 | FDA UDI | Class II | Active |
| Skyn | 08859798105822 | FDA UDI | Class II | Active |
| Lifestyles | 08859798107277 | FDA UDI | Class II | Active |
| Skyn | 08859798100667 | FDA UDI | Class II | Active |
| Skyn | 3120 | FDA UDI | Class II | Active |
| Skyn | 08859798101503 | FDA UDI | Class II | Active |
| Skyn | 0108 | FDA UDI | Class II | Active |
| Lifestyles | 08859798101039 | FDA UDI | Class II | Active |
| Lifestyles | 08859798100513 | FDA UDI | Class II | Active |
| Lifestyles | 3021 | FDA UDI | Class II | Active |
| Lifestyles | 0024 | FDA UDI | Class II | Active |
| Lifestyles | 8502 | FDA UDI | Class II | Active |
| Lifestyles | 9800 | FDA UDI | Class II | Active |
| Lifestyles | 08859798101572 | FDA UDI | Class II | Active |
| Lifestyles | 08859798106591 | FDA UDI | Class II | Active |
| Lifestyles | 08859798100568 | FDA UDI | Class II | Active |
| Skyn | 7300 | FDA UDI | Class II | Active |
| Skyn | 08859798107321 | FDA UDI | Class II | Active |
| Skyn | 08859798100933 | FDA UDI | Class II | Active |
| Lifestyles | 08859798101626 | FDA UDI | Class II | Active |
| Lifestyles | 0210 | FDA UDI | Class II | Active |
| Steamworks Non Lubricated Condom | 08859798104979 | FDA UDI | Class II | Active |
| Lifestyles | 0084 | FDA UDI | Class II | Active |
| Skyn | 3003 | FDA UDI | Class II | Active |
| Skyn | 0107 | FDA UDI | Class II | Active |
| Skyn | 08859798100841 | FDA UDI | Class II | Active |
| Skyn | 08859798107154 | FDA UDI | Class II | Active |
| Skyn | 08859798101657 | FDA UDI | Class II | Active |
| Skyn | 08859798100452 | FDA UDI | Class II | Active |
| Skyn | 0114 | FDA UDI | Class II | Active |
| Skyn | 08859798106997 | FDA UDI | Class II | Active |
| Skyn | 7103 | FDA UDI | Class II | Active |
| Skyn | 08859798101978 | FDA UDI | Class II | Active |
| Skyn | 08859798100049 | FDA UDI | Class II | Active |
| Skyn | 08859798101473 | FDA UDI | Class II | Active |
| Lifestyles | 08859798101541 | FDA UDI | Class II | Active |
| Skyn | 08859798100018 | FDA UDI | Class II | Active |
| Lifestyles | 08859798101145 | FDA UDI | Class II | Active |
| Skyn | 08859798100711 | FDA UDI | Class II | Active |
| Skyn | 08859798100216 | FDA UDI | Class II | Active |
| Skyn | 3118 | FDA UDI | Class II | Active |
| Lifestyles | 08859798100483 | FDA UDI | Class II | Active |
| Lifestyles | 5800 | FDA UDI | Class II | Active |
| Skyn | 08859798100865 | FDA UDI | Class II | Active |
| Lifestyles | 08859798101152 | FDA UDI | Class II | Active |
| Skyn | 08859798100148 | FDA UDI | Class II | Active |
| Skyn | 08859798100438 | FDA UDI | Class II | Active |
| Lifestyles | 3040 | FDA UDI | Class II | Active |
| Lifestyles | 0022 | FDA UDI | Class II | Active |
| Lifestyles | 08859798107383 | FDA UDI | Class II | Active |
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