Data / Medical devices / Thailand / Thaimed Hightech Co.,Ltd.
Thaimed Hightech Co.,Ltd.: FDA-registered device maker in Kabinburi Prachin Buri, Thailand, 1 510(k) clearance
Thaimed Hightech Co.,Ltd. is registered with the FDA (registration 3012134276) in Kabinburi Prachin Buri, Thailand. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 27, 2010. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012134276
- Address
- 612/18 M.9 Kabinburi Industrial Zone, Nongkee, Kabinburi Prachin Buri, Thailand, 25110
- Owner or operator
- MAM Baby AG (9054867)
- Roles
- Manufacturer
- First device listed
- July 23, 2009
- Registered through
- 2026
- Brand names listed
- Bite & Brush, MAM Cooler, Mini Cooler, Bite & Play, Oral Care Rabbit, Starter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Pick, Massaging | JET | 1 | Manufacturer | accessdata.fda.gov |
| Ring, Teething, Fluid-Filled | KKO | 2 | Manufacturer | accessdata.fda.gov |
| Ring, Teething, Non-Fluid Filled | MEF | 1 | 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 |
|---|---|---|---|---|---|---|
| July 27, 2010 | K093266 | MAM COOLER | KKO | Substantially Equivalent | Mam International AG | accessdata.fda.gov |
Compare with other makers
- All makers of Ring, Teething, Fluid-Filled
- All makers of Pick, Massaging
- All makers of Ring, Teething, Non-Fluid Filled
Updated July 27, 2010. 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.