# Demask Dortmund · 89-08 · GERMANY — FDA import alert red lists: firms subject to detention without physical examination

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: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** 44135 Dortmund , Hamburger Str. 120 , Dortmund, North Rhine-Westphalia GERMANY _(verified: appears in the quote below)_
- **Date published:** 03/01/2011 _(verified: appears in the quote below)_
- **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 _(verified: each item appears in the quote below)_
- **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 _(verified: each item appears in the quote below)_
- **FDA notes:** Class II | Class II | Class II | Class II | Class II | Class II | Class II | Class II | Class II _(verified: each item appears in the quote below)_

## 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

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).