Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009973692

FEI Number

3009973692

Entity Name

Elemaster Spa

City/State/Country

lomagna Lecco, IT

Establishment Address

Via Garcia Lorca 29, lomagna Lecco 23871, IT

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Elemaster SpA (Owner Number: 10051862)

Owner / Operator Contact Address

via Garcia Lorca, 29, Lomagna, IT-LC 23871, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MAIA Centervue

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MYC	Ophthalmoscope, Laser, Scanning	Ophthalmic	Class 2	886.1570	2025-04-16
MYC	Ophthalmoscope, Laser, Scanning	Ophthalmic	Class 2	886.1570	2016-05-12
HPT	Perimeter, Automatic, Ac-Powered	Ophthalmic	Class 1	886.1605	2016-05-12

Official Correspondent

Alessandro Riva

US Agent Details

STEVE WITTY Email: steve.witty@icare-world.com Phone: (844) 2134408

Related Public Records

Same Entity

Elemaster SpA

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 3009973692. Last updated year: 2026. Please use registration number 3009973692 when referencing this establishment in official correspondence.