# Mt.Derm Gmbh · 89-08 · GERMANY — FDA import alert red lists: firms subject to detention without physical examination

For Mt.Derm 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 is Microneedling device | Microneedling device | Manual surgical instrument for general use | Surgical instrument motors and accessories/attachments | Amiea Vytal Skin Microneedling Machine (aesthetic use); product code is 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 79 G - - AR Suture, Nonabsorbable, Synthetic, Polyamide | 79 G - - ED Brush, Dermabrasion, Manual | 79 G - - FE Brush, Dermabrasion | 79 Q - - AI Powered microneedle device; date published is 10/02/2015; address is Gustav-Krone-Str. 3 , Berlin, Berlin GERMANY, verified against its source on 2026-09-16.

- **Firm:** Mt.Derm 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:** Gustav-Krone-Str. 3 , Berlin, Berlin GERMANY _(verified: appears in the quote below)_
- **Date published:** 10/02/2015 _(verified: appears in the quote below)_
- **Product code:** 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 79 G - - AR Suture, Nonabsorbable, Synthetic, Polyamide | 79 G - - ED Brush, Dermabrasion, Manual | 79 G - - FE Brush, Dermabrasion | 79 Q - - AI Powered microneedle device _(verified: each item appears in the quote below)_
- **Product:** Microneedling device | Microneedling device | Manual surgical instrument for general use | Surgical instrument motors and accessories/attachments | Amiea Vytal Skin Microneedling Machine (aesthetic use) _(verified: each item appears in the quote below)_
- **FDA notes:** Class II | Class II | Class I | Class I | Class II 12/14/2025 _(verified: each item appears in the quote below)_

## What the source says

> Mt.Derm Gmbh Date Published : 10/02/2015 Gustav-Krone-Str. 3 , Berlin, Berlin GERMANY 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 04/24/2017 Desc: Microneedling device Notes: Class II 79 G - - AR Suture, Nonabsorbable, Synthetic, Polyamide Date Published: 10/02/2015 Desc: Microneedling device Notes: Class II 79 G - - ED Brush, Dermabrasion, Manual Date Published: 12/05/2025 Desc: Manual surgical instrument for general use Notes: Class I 79 G - - FE Brush, Dermabrasion Date Published: 12/05/2025 Desc: Surgical instrument motors and accessories/attachments Notes: Class I 79 Q - - AI Powered microneedle device Date Published: 06/04/2026 Desc: Amiea Vytal Skin Microneedling Machine (aesthetic use) Notes: Class II 12/14/2025

## 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/).