Data / Medical devices / Laos
Medical device makers in Laos: 3 FDA-registered establishments
3 establishments in Laos are registered with the FDA to make medical devices for the US market, listing 10 device types. 1 has a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.
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- LaosCountry
Device types made here
Device types with the most registered makers in this country.
| Device | Product code | Makers |
|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 |
| Mask, Surgical | FXX | 1 |
| Non-Surgical Gown | OEA | 1 |
| Gown, Examination | FME | 1 |
| Massager, Therapeutic, Electric | ISA | 1 |
| Sunglasses (Non-Prescription Including Photosensitive) | HQY | 1 |
| Lens, Spectacle, Non-Custom (Prescription) | HQG | 1 |
| Gown, Isolation, Surgical | FYC | 1 |
| Pediatric/Child Facemask | OXZ | 1 |
| Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs | QSO | 1 |
Makers in Laos
Best documented first: most 510(k) clearances and PMA approvals.
| Maker | Location | Device types | 510(k) clearances | PMA approvals | Recall events | Source |
|---|---|---|---|---|---|---|
| PRIMED Laos Medical Products Manufacturing Sole Co., Ltd. | Vientiane Capital Viangchan(Prefecture), Laos | 7 | 1 | 0 | 0 | api.fda.gov |
| Essilor Lao Company Limited | Savannakhet, Laos | 1 | 0 | 0 | 0 | api.fda.gov |
| Leader Lao Co.,ltd | Kaysone Phomvihane Savannakhet, Laos | 2 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 2026. 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.