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

For DERMAROLLER GMBH · 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 code is 73 - - - -- Anesthesiology | 74 - - - -- Cardiovascular | 76 - - - -- Dental | 77 - - - -- Ear,Nose And Throat | 78 - - - -- Gastroenterological & Urological | 79 - - - -- General & Plastic Surgery | 80 - - - -- General Hospital/Personal Use | 84 - - - -- Neurological | 85 - - - -- Obstetrical & Gynecological | 86 - - - -- Ophthalmic | 87 - - - -- Orthopedic | 89 - - - -- Physical Medicine | 90 - - - -- Radiology; date published is 03/13/2013; address is Lindener Str. 15 , Wolfenbuttel, Lower Saxony GERMANY, verified against its source on 2026-09-16.

- **Firm:** DERMAROLLER GMBH _(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:** Lindener Str. 15 , Wolfenbuttel, Lower Saxony GERMANY _(verified: appears in the quote below)_
- **Date published:** 03/13/2013 _(verified: appears in the quote below)_
- **Product code:** 73 - - - -- Anesthesiology | 74 - - - -- Cardiovascular | 76 - - - -- Dental | 77 - - - -- Ear,Nose And Throat | 78 - - - -- Gastroenterological & Urological | 79 - - - -- General & Plastic Surgery | 80 - - - -- General Hospital/Personal Use | 84 - - - -- Neurological | 85 - - - -- Obstetrical & Gynecological | 86 - - - -- Ophthalmic | 87 - - - -- Orthopedic | 89 - - - -- Physical Medicine | 90 - - - -- Radiology _(verified: each item appears in the quote below)_
- **FDA notes:** All Devices;class I/II/III | All Devices;class I/II/III | All Devices;class I/II/III | All Devices;class I/II/III | All Devices;class I/II/III | All Devices;class I/II/III | All Devices;class I/II/III | All Devices;class I/II/III | All Devices;class I/II/III | All Devices;class I/II/III | All Devices;class I/II/III | All Devices;class I/II/III | All Devices;class I/II/III _(verified: each item appears in the quote below)_

## What the source says

> DERMAROLLER GMBH Date Published : 03/13/2013 Lindener Str. 15 , Wolfenbuttel, Lower Saxony GERMANY 73 - - - -- Anesthesiology Date Published: 03/13/2013 Notes: All Devices;class I/II/III 74 - - - -- Cardiovascular Date Published: 03/13/2013 Notes: All Devices;class I/II/III 76 - - - -- Dental Date Published: 03/13/2013 Notes: All Devices;class I/II/III 77 - - - -- Ear,Nose And Throat Date Published: 03/13/2013 Notes: All Devices;class I/II/III 78 - - - -- Gastroenterological & Urological Date Published: 03/13/2013 Notes: All Devices;class I/II/III 79 - - - -- General & Plastic Surgery Date Published: 03/13/2013 Notes: All Devices;class I/II/III 80 - - - -- General Hospital/Personal Use Date Published: 03/13/2013 Notes: All Devices;class I/II/III 84 - - - -- Neurological Date Published: 03/13/2013 Notes: All Devices;class I/II/III 85 - - - -- Obstetrical & Gynecological Date Published: 03/13/2013 Notes: All Devices;class I/II/III 86 - - - -- Ophthalmic Date Published: 03/13/2013 Notes: All Devices;class I/II/III 87 - - - -- Orthopedic Date Published: 03/13/2013 Notes: All Devices;class I/II/III 89 - - - -- Physical Medicine Date Published: 03/13/2013 Notes: All Devices;class I/II/III 90 - - - -- Radiology Date Published: 03/13/2013 Notes: All Devices;class I/II/III

## 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/).