Uniqso Holdings Sdn Bhd · 89-08 · MALAYSIA
For Uniqso Holdings Sdn Bhd · 89-08 · MALAYSIA, import alert is 89-08; 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)"; country is MALAYSIA; 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 2026-09-16.
- 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 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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html