Reference Source

EMA AESTHETIC LIMITED · 89-08 · IRELAND

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
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 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 each item verified
Product
Collagen handpiece | MicroT handpiece | Collagen handpiece | Preime Dermafacial Device | MicroT handpiece each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

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

accessdata.fda.gov, retrieved 2026-09-15

Source

Last verified against source: . Due for re-check by . This page as Markdown · OKF bundle · full dataset as JSON.

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