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Innolatex (Thailand) Limited

Active in EUDAMED

Thailandfrom SRN EUDAMED FDA SRN TH-MF-000001249 FEI 3007829481

Devices
208
Registrations
EUDAMEDFDA
FDA recalls
0

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA FEI
Authorised rep.
Advena LimitedMT

What Innolatex (Thailand) Limited makes

Innolatex (Thailand) Limited manufactures a range of barrier contraceptive products and personal lubricants, including various Durex condom models such as Nude, Intensity, and Super Thin, as well as flavored and extra‑lubricated versions, and PASANTE condom lines.

The portfolio includes devices classified as Class I, Class II, and Class IIb and is listed in the EU MDR database (Eudamed) and the U.S. FDA 510(k) system; the company is based in Thailand.

AI-generated from registry data, 6 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue208

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Company details

EUDAMED SRN
TH-MF-000001249
FDA FEI number
3007829481
EUDAMED status
Active
EUDAMED registered name
Innolatex (Thailand) Limited
EUDAMED abbreviated name
ITL
Registered address
E 1-6 Export Processing Zone, Southern Industrial Estate,, 90110, Songkhla, Thailand
Phone
+03 3165 6688
PRRC contact
Ivy Wen June Ng(public in EUDAMED)

From the company website

Read 18 Oct 2026

Karex, World’s Largest Condom Maker, is a listed company on the Main Market of Bursa Malaysia Securities Berhad.

From the manufacturer's own website. Source

Frequently asked questions

How many devices does Innolatex (Thailand) Limited have in the registry?

The registry currently lists 208 devices for Innolatex (Thailand) Limited. Devices recorded under merged duplicate company entries are counted once.

Which registries list Innolatex (Thailand) Limited's devices?

Among its 50 most recently registered devices, Innolatex (Thailand) Limited has devices listed in EUDAMED (50 devices).

What risk classes do Innolatex (Thailand) Limited's devices fall under?

Among its 50 most recently registered devices, the classes recorded for Innolatex (Thailand) Limited's devices are Class IIb. Each device page shows its own class and authorisation.

What are the newest devices from Innolatex (Thailand) Limited in the registry?

The most recently registered devices listed for Innolatex (Thailand) Limited include Pasante Extra, Kung Loose, Pasante Taste and Durex Intensity.

Generated automatically from registry data and not verified by a human reviewer.