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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 3 of 8
DeviceModel / ReferenceRegistriesClassStatus
Lifestyles 08859798101565
FDA UDI
Class IIActive
Skyn 08859798100728
FDA UDI
Class IIActive
Skyn 08859798107024
FDA UDI
Class IIActive
Skyn 0939
FDA UDI
Class IIActive
Skyn 0059
FDA UDI
Class IIActive
Skyn 08859798106966
FDA UDI
Class IIActive
Lifestyles 08859798106737
FDA UDI
Class IIActive
Skyn 08859798101343
FDA UDI
Class IIActive
Skyn 7210
FDA UDI
Class IIActive
Lifestyles 08859798100100
FDA UDI
Class IIActive
Skyn 08859798105471
FDA UDI
Class IIActive
Skyn 1101
FDA UDI
Class IIActive
Skyn 08859798101442
FDA UDI
Class IIActive
Lifestyles 3042
FDA UDI
Class IIActive
Lifestyles 1803
FDA UDI
Class IIActive
LifeStyles 08859798105914
FDA UDI
Class IIActive
Skyn 08859798100445
FDA UDI
Class IIActive
Lifestyles 8101
FDA UDI
Class IIActive
Lifestyles 08859798107284
FDA UDI
Class IIActive
Lifestyles 08859798105426
FDA UDI
Class IIActive
Lifestyles 08859798100674
FDA UDI
Class IIActive
Lifestyles 08859798101619
FDA UDI
Class IIActive
Skyn 08859798106003
FDA UDI
Class IIActive
Skyn 08859798101213
FDA UDI
Class IIActive
Lifestyles 08859798101107
FDA UDI
Class IIActive
Skyn 8201
FDA UDI
Class IIActive
Lifestyles 1712
FDA UDI
Class IIActive
Lifestyles 0910
FDA UDI
Class IIActive
Lifestyles 08859798101206
FDA UDI
Class IIActive
Lifestyles 0742
FDA UDI
Class IIActive
Lifestyles 08859798101084
FDA UDI
Class IIActive
Lifestyles 3122
FDA UDI
Class IIActive
Lifestyles 1272
FDA UDI
Class IIActive
Lifestyles 08859798100476
FDA UDI
Class IIActive
Skyn 08859798100858
FDA UDI
Class IIActive
Skyn 0125
FDA UDI
Class IIActive
LIfestyles 9588
FDA UDI
Class IIActive
Skyn 0060
FDA UDI
Class IIActive
Skyn 7324
FDA UDI
Class IIActive
Skyn 9318
FDA UDI
Class IIActive
Lifestyles 08859798100964
FDA UDI
Class IIActive
Lifestyles 0109
FDA UDI
Class IIActive
Skyn 08859798101220
FDA UDI
Class IIActive
Skyn 0062
FDA UDI
Class IIActive
Lifestyles 1703
FDA UDI
Class IIActive
Rider 9857
FDA UDI
Class IIActive
Skyn 08859798107314
FDA UDI
Class IIActive
Lifestyles 08859798101114
FDA UDI
Class IIActive
Skyn 0126
FDA UDI
Class IIActive
Lifestyles 08859798101633
FDA UDI
Class IIActive

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