Demask Dortmund · 89-08 · GERMANY
For Demask Dortmund, import alert is 89-08; country is GERMANY; 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 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 2026-09-30.
- 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
— 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: 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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html