EMA AESTHETIC LIMITED · 89-08 · IRELAND
For EMA AESTHETIC LIMITED, import alert is 89-08; country is IRELAND; 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 Preime Dermafacial Device | Collagen handpiece | Collagen handpiece | MicroT handpiece | MicroT handpiece; product code is 79 - - - -- General & Plastic Surgery | 79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories | 79 G - - FE Brush, Dermabrasion | 79 G - - FE Brush, Dermabrasion | 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 2026-09-30.
- Firm
- EMA AESTHETIC LIMITED 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
- IRELAND verified
- Address
- Palmerston House , Fenian Street , Dublin, IRELAND verified
- Date published
- 12/03/2024 verified
- Product code
- 79 - - - -- General & Plastic Surgery | 79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories | 79 G - - FE Brush, Dermabrasion | 79 G - - FE Brush, Dermabrasion | 84 N - - UH Stimulator, Nerve, Transcutaneous, Over-The-Counter each item verified
- Product
- Preime Dermafacial Device | Collagen handpiece | Collagen handpiece | MicroT handpiece | MicroT handpiece each item verified
What the source says
EMA AESTHETIC LIMITED Date Published : 12/03/2024 Palmerston House , Fenian Street , Dublin, IRELAND
— accessdata.fda.gov, retrieved 2026-09-22
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 and Product
79 - - - -- General & Plastic Surgery Date Published: 12/03/2024 Desc: Preime Dermafacial Device 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: Collagen handpiece 79 G - - FE Brush, Dermabrasion Date Published: 12/03/2024 Desc: MicroT handpiece 84 N - - UH Stimulator, Nerve, Transcutaneous, Over-The-Counter Date Published: 12/03/2024 Desc: MicroT handpiece
— all from accessdata.fda.gov, retrieved 2026-09-22
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html