Data / Medical devices / Malaysia / Eurolatex Sdn Bhd
Eurolatex Sdn Bhd: FDA-registered device maker in Kedah, Malaysia, 1 510(k) clearance
Eurolatex Sdn Bhd is registered with the FDA (registration 3010599708) in Kedah, Malaysia. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated February 17, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010599708
- Address
- Plot 33, Kuala Ketil Industrial Estate Kuala Ketil, Kedah, Malaysia, 09300
- Owner or operator
- EUROLATEX SDN BHD (10084503)
- Roles
- Manufacturer
- First device listed
- March 1, 2022
- Registered through
- 2026
- Brand names listed
- Caliber
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Condom | HIS | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 17, 2022 | K210208 | Titan Condoms | HIS | Substantially Equivalent | Titan Condoms, LLC | accessdata.fda.gov |
Compare with other makers
Updated February 17, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.