Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021177911

FEI Number

3021177911

Entity Name

EMA AESTHETIC LTD

City/State/Country

Dublin Dublin (City), IE

Establishment Address

Waterloo Exchange, Waterloo Road, Dublin Dublin (City) D04 E5W7, IE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

EMA Aesthetic Limited (Owner Number: 10083797)

Owner / Operator Contact Address

Palmerston House, Fenian Street, Dublin 2, Ireland, Dublin, IE-DU D02 WD37, IE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Preime DermaFacial - VibroX Preime DermaFacial - AquaB

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2024-12-02
GFE	Brush, Dermabrasion, Powered	General, Plastic Surgery	Class 1	878.4820	2021-12-20

Official Correspondent

Alice Daniels

US Agent Details

Connie Hoy Business: Hoy & Associate LLC Email: conniehoy@hoyregulatory.com Phone: (530) 9084903

Related Public Records

Same Entity

EMA Aesthetic Limited

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021177911. Last updated year: 2026. Please use registration number 3021177911 when referencing this establishment in official correspondence.