Data / Medical devices / Malaysia / Fitson Sdn Bhd
Fitson Sdn Bhd: FDA-registered device maker in Senai Johor, Malaysia, 1 510(k) clearance
Fitson Sdn Bhd is registered with the FDA (registration 3004957421) in Senai Johor, Malaysia. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 18, 2009. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004957421
- Address
- 19 Jalan I-Park SAC 3 Taman Perindustrian I-Park SAC, Senai Johor, Malaysia, 81400
- Owner or operator
- Fitson Sdn Bhd (10029016)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- May 27, 2009
- Registered through
- 2026
- Brand names listed
- Allegre Puericulture SAS, Hegen Pte Ltd, Laboratoires Polive, Nurnberg Gummi Babyartikel GmbH & Co. Kg, Pigeon Singapore Pte Ltd
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Pump, Breast, Non-Powered | HGY | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Ring, Teething, Fluid-Filled | KKO | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Ring, Teething, Non-Fluid Filled | MEF | 1 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| June 18, 2009 | K090167 | PHILIPS AVENT CLASSIC STAGE 2 AND 3 TEETHER, MODEL SCF882/01, SCF884/01, PHILIPS AVENT ANIMAL STAGE 2 AND 3 TEETHER, | KKO | Substantially Equivalent | Philips Electronics UK Limited | accessdata.fda.gov |
Compare with other makers
- All makers of Ring, Teething, Non-Fluid Filled
- All makers of Pump, Breast, Non-Powered
- All makers of Ring, Teething, Fluid-Filled
Updated June 18, 2009. 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.