# EMA AESTHETIC LIMITED · 89-08 · IRELAND — FDA import alert red lists: firms subject to detention without physical examination

For EMA AESTHETIC LIMITED · 89-08 · IRELAND, 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 IRELAND; product is Collagen handpiece | MicroT handpiece | Collagen handpiece | Preime Dermafacial Device | MicroT handpiece; product code is 79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories | 79 G - - FE Brush, Dermabrasion | 79 G - - FE Brush, Dermabrasion | 79 - - - -- General & Plastic Surgery | 84 N - - UH Stimulator, Nerve, Transcutaneous, Over-The-Counter; date published is 12/03/2024; address is Palmerston House , Fenian Street , Dublin, IRELAND, verified against its source on 2026-09-16.

- **Firm:** EMA AESTHETIC LIMITED _(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:** IRELAND _(verified: appears in the quote below)_
- **Address:** Palmerston House , Fenian Street , Dublin, IRELAND _(verified: appears in the quote below)_
- **Date published:** 12/03/2024 _(verified: appears in the quote below)_
- **Product code:** 79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories | 79 G - - FE Brush, Dermabrasion | 79 G - - FE Brush, Dermabrasion | 79 - - - -- General & Plastic Surgery | 84 N - - UH Stimulator, Nerve, Transcutaneous, Over-The-Counter _(verified: each item appears in the quote below)_
- **Product:** Collagen handpiece | MicroT handpiece | Collagen handpiece | Preime Dermafacial Device | MicroT handpiece _(verified: each item appears in the quote below)_

## What the source says

> EMA AESTHETIC LIMITED Date Published : 12/03/2024 Palmerston House , Fenian Street , Dublin, IRELAND 79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories Date Published: 12/03/2024 Desc: Collagen handpiece 79 G - - FE Brush, Dermabrasion Date Published: 12/03/2024 Desc: MicroT handpiece 79 G - - FE Brush, Dermabrasion Date Published: 12/03/2024 Desc: Collagen handpiece 79 - - - -- General & Plastic Surgery Date Published: 12/03/2024 Desc: Preime Dermafacial Device 84 N - - UH Stimulator, Nerve, Transcutaneous, Over-The-Counter Date Published: 12/03/2024 Desc: MicroT handpiece

## 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/).