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SURETEX LIMITED - BRANCH

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
—
LinkedIn
—
Facebook
—
Phone
8482293224
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
672044515

Catalogue (397)

Page 8 of 8
DeviceModel / ReferenceRegistriesClassStatus
Lifestyles 9103
FDA UDI
Class IIActive
Lifestyles 8701
FDA UDI
Class IIActive
Lifestyles 0013
FDA UDI
Class IIActive
Skyn 0102
FDA UDI
Class IIActive
Skyn 08859798100605
FDA UDI
Class IIActive
Lifestyles 08859798100506
FDA UDI
Class IIActive
Skyn 08859798100209
FDA UDI
Class IIActive
Skyn 08859798105778
FDA UDI
Class IIActive
Lifestyles 2028
FDA UDI
Class IIActive
LifeStyles 08859798107130
FDA UDI
Class IIActive
Ultra Shape Colors 08859798104924
FDA UDI
Class IIActive
Savage Bliss 08859798105037
FDA UDI
Class IIActive
Skyn 0014
FDA UDI
Class IIActive
Lifestyles 6800
FDA UDI
Class IIActive
Skyn 08859798107123
FDA UDI
Class IIActive
Rider 9855
FDA UDI
Class IIActive
Lifestyles 5801
FDA UDI
Class IIActive
Lifestyles 08859798101091
FDA UDI
Class IIActive
Skyn 08859798106492
FDA UDI
Class IIActive
Lifestyles 08859798100490
FDA UDI
Class IIActive
Skyn 7403
FDA UDI
Class IIActive
Lifestyles 08859798106485
FDA UDI
Class IIActive
Skyn 08859798105884
FDA UDI
Class IIActive
Skyn 08859798100780
FDA UDI
Class IIActive
Lifestyles 08859798100469
FDA UDI
Class IIActive
Skyn 08859798100636
FDA UDI
Class IIActive
Lifestyles 08859798100575
FDA UDI
Class IIActive
Skyn 08859798103132
FDA UDI
Class IIActive
Lifestyles 08859798106447
FDA UDI
Class IIActive
Skyn 0063
FDA UDI
Class IIActive
Skyn 08859798101312
FDA UDI
Class IIActive
Skyn 08859798100124
FDA UDI
Class IIActive
Skyn 08859798100810
FDA UDI
Class IIActive
Skyn 08859798100254
FDA UDI
Class IIActive
Lifestyles 08859798100971
FDA UDI
Class IIActive
Skyn 08859798100414
FDA UDI
Class IIActive
Lifestyles 0021
FDA UDI
Class IIActive
Lifestyles 08859798100995
FDA UDI
Class IIActive
Lifestyles 08859798106454
FDA UDI
Class IIActive
Skyn 08859798106041
FDA UDI
Class IIActive
Lifestyles 08859798105433
FDA UDI
Class IIActive
Lifestyles 08859798101138
FDA UDI
Class IIActive
Lifestyles 7000
FDA UDI
Class IIActive
Bikini 08859798105020
FDA UDI
Class IIActive
Philly 08859798104993
FDA UDI
Class IIActive
Steamworks Lubricated Condom 08859798104962
FDA UDI
Class IIActive
Adam & Eve 08859798104900
FDA UDI
Class IIActive

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