Demask Dortmund · 89-08 · GERMANY
For Demask Dortmund · 89-08 · GERMANY, 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 GERMANY; product is Pocket Darkroom Contact Lenses | Pocket Darkroom Contact Lenses | Pocket Darkroom Contact Lenses | Pocket Darkroom Contact Lenses | Pocket Darkroom Contact Lenses | Pocket Darkroom Contact Lenses | Pocket Darkroom Contact Lenses | Pocket Darkroom Contact Lenses | Pocket Darkroom Contact Lenses; product code is 86 H - - PX Lens, Contact (Polymethylmethacrylate) | 86 H - - QD Lens, Contact (Other Material) - Daily | 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 03/01/2011; address is 44135 Dortmund , Hamburger Str. 120 , Dortmund, North Rhine-Westphalia GERMANY, verified against its source on 2026-09-16.
- Firm
- Demask Dortmund 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
- GERMANY verified
- Address
- 44135 Dortmund , Hamburger Str. 120 , Dortmund, North Rhine-Westphalia GERMANY verified
- Date published
- 03/01/2011 verified
- Product code
- 86 H - - PX Lens, Contact (Polymethylmethacrylate) | 86 H - - QD Lens, Contact (Other Material) - Daily | 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
- Pocket Darkroom Contact Lenses | Pocket Darkroom Contact Lenses | Pocket Darkroom Contact Lenses | Pocket Darkroom Contact Lenses | Pocket Darkroom Contact Lenses | Pocket Darkroom Contact Lenses | Pocket Darkroom Contact Lenses | Pocket Darkroom Contact Lenses | Pocket Darkroom Contact Lenses each item verified
- FDA notes
- Class II | Class II | Class II | Class II | Class II | Class II | Class II | Class II | Class II each item verified
What the source says
Demask Dortmund Date Published : 03/01/2011 44135 Dortmund , Hamburger Str. 120 , Dortmund, North Rhine-Westphalia GERMANY 86 H - - PX Lens, Contact (Polymethylmethacrylate) Date Published: 03/01/2011 Desc: Pocket Darkroom Contact Lenses Notes: Class II 86 H - - QD Lens, Contact (Other Material) - Daily Date Published: 03/01/2011 Desc: Pocket Darkroom Contact Lenses Notes: Class II 86 L - - PL Lenses, Soft Contact, Daily Wear Date Published: 03/01/2011 Desc: Pocket Darkroom Contact Lenses Notes: Class II 86 L - - PM Lenses, Soft Contact, Extended Wear Date Published: 03/01/2011 Desc: Pocket Darkroom Contact Lenses Notes: Class II 86 M - - UW Lens, Contact (Orthokeratology) Date Published: 03/01/2011 Desc: Pocket Darkroom Contact Lenses Notes: Class II 86 M - - VN Lens, Contact (Disposable) Date Published: 03/01/2011 Desc: Pocket Darkroom Contact Lenses Notes: Class II 86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear Date Published: 03/01/2011 Desc: Pocket Darkroom Contact Lenses Notes: Class II 86 N - - CZ Lens, Contact, for Color Vision Deficiency Date Published: 03/01/2011 Desc: Pocket Darkroom Contact Lenses Notes: Class II 86 N - - IC Lens, Contact, for Reading Discomfort Date Published: 03/01/2011 Desc: Pocket Darkroom Contact Lenses Notes: Class II
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html