Uniqso Holdings Sdn Bhd · 89-08 · MALAYSIA
For Uniqso Holdings Sdn Bhd, import alert is 89-08; country is MALAYSIA; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; product is Contact lenses | Contact lenses | Contact lenses | Contact lenses | Contact lenses | Contact lenses | Contact lenses | Contact lenses; product code is 86 H - - PX Lens, Contact (Polymethylmethacrylate) | 86 L - - PL Lenses, Soft Contact, Daily Wear | 86 L - - PM Lenses, Soft Contact, Extended Wear | 86 M - - UW Lens, Contact (Orthokeratology) | 86 M - - VN Lens, Contact (Disposable) | 86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear | 86 N - - CZ Lens, Contact, for Color Vision Deficiency | 86 N - - IC Lens, Contact, for Reading Discomfort; date published is 02/03/2016; address is Jalan Balakong Batu , 1/2 , Cheras, Selangor MALAYSIA, verified against its source on 2026-09-30.
- Firm
- Uniqso Holdings Sdn Bhd verified
- Import alert
- 89-08
- Import alert name
- "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- Country
- MALAYSIA verified
- Address
- Jalan Balakong Batu , 1/2 , Cheras, Selangor MALAYSIA verified
- Date published
- 02/03/2016 verified
- Product code
- 86 H - - PX Lens, Contact (Polymethylmethacrylate) | 86 L - - PL Lenses, Soft Contact, Daily Wear | 86 L - - PM Lenses, Soft Contact, Extended Wear | 86 M - - UW Lens, Contact (Orthokeratology) | 86 M - - VN Lens, Contact (Disposable) | 86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear | 86 N - - CZ Lens, Contact, for Color Vision Deficiency | 86 N - - IC Lens, Contact, for Reading Discomfort each item verified
- Product
- Contact lenses | Contact lenses | Contact lenses | Contact lenses | Contact lenses | Contact lenses | Contact lenses | Contact lenses each item verified
- FDA notes
- 2/3/2016 verified
What the source says
Uniqso Holdings Sdn Bhd Date Published : 02/03/2016 Jalan Balakong Batu , 1/2 , Cheras, Selangor MALAYSIA
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
86 H - - PX Lens, Contact (Polymethylmethacrylate) Date Published: 02/03/2016 Desc: Contact lenses 86 L - - PL Lenses, Soft Contact, Daily Wear Date Published: 02/03/2016 Desc: Contact lenses 86 L - - PM Lenses, Soft Contact, Extended Wear Date Published: 02/03/2016 Desc: Contact lenses 86 M - - UW Lens, Contact (Orthokeratology) Date Published: 02/03/2016 Desc: Contact lenses 86 M - - VN Lens, Contact (Disposable) Date Published: 02/03/2016 Desc: Contact lenses 86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear Date Published: 01/30/2019 Desc: Contact lenses Notes: 2/3/2016 86 N - - CZ Lens, Contact, for Color Vision Deficiency Date Published: 02/03/2016 Desc: Contact lenses 86 N - - IC Lens, Contact, for Reading Discomfort Date Published: 02/03/2016 Desc: Contact lenses
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html