Data / Medical devices / Malaysia / Maxvue Vision Sdn. Bhd.
Maxvue Vision Sdn. Bhd.: FDA-registered device maker in Seremban Negeri Sembilan, Malaysia, 1 510(k) clearance
Maxvue Vision Sdn. Bhd. is registered with the FDA (registration 3012760082) in Seremban Negeri Sembilan, Malaysia. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 22, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012760082
- Address
- 280B, Jalan Haruan 1 Oakland Industrial Park, Seremban Negeri Sembilan, Malaysia, 70300
- Owner or operator
- Maxvue Vision Sdn. Bhd. (10059252)
- Roles
- Exporter to the US, Repackager or relabeler
- First device listed
- April 13, 2026
- Registered through
- 2026
- Brand names listed
- Chromaview Eyefx , Colourvue, Phantasee , Maxvue Hydrosoft, Maxvue HydroHD
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lens, Contact, (Disposable) | MVN | 2 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Lenses, Soft Contact, Daily Wear | LPL | 2 | Exporter to the US, Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| August 22, 2016 | K161098 | ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/Color) | LPL | Substantially Equivalent | Joowon Innovation Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated August 22, 2016. 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.