Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016899893

FEI Number

3016899893

Entity Name

ELMAC ELETTRONICA S.R.L.

City/State/Country

Tavullia Pesaro e Urbino, IT

Establishment Address

Str. delle Campagne, 14, Tavullia Pesaro e Urbino 61010, IT

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

ELMAC ELETTRONICA S.R.L. (Owner Number: 10094723)

Owner / Operator Contact Address

Str. delle Campagne, 14, Tavullia, IT-PU 61010, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

1NEED Pro

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QAI	Powered Microneedle Device	General, Plastic Surgery	Class 2	878.4430	2025-12-18

Official Correspondent

Michele Pensalfini

US Agent Details

Jay Mansour Email: jay@mansourconsulting.com Phone: (678) 9088180

Related Public Records

Same Entity

ELMAC ELETTRONICA S.R.L.

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 3016899893. Last updated year: 2026. Please use registration number 3016899893 when referencing this establishment in official correspondence.