Metaltronica Spa

FDA Device Registration & Listing · Pomezia Roma, IT · Registration 3009868110

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3009868110
FEI Number
3009868110
Entity Name
Metaltronica Spa
City/State/Country
Pomezia Roma, IT
Establishment Address
Pomezia (RM) via delle Monachelle 66, Pomezia Roma 00071, IT
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
SEDECAL S.A. (Owner Number: 9039772)
Owner / Operator Contact Address
PELAYA, 9 POL., POL. IND. "RIO DE JANEIRO", ALGETE, ES-M 28110, ES
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K202822
PMA Number
N/A

All Registered Proprietary Names

Helianthus Serenys DR

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MUE Full Field Digital, System, X-Ray, Mammographic Radiology Class 2 892.1715 2023-10-05

Official Correspondent

No official correspondent registered.

US Agent Details

Devan Moser Business: Sedecal USA Inc. Email: DMOSER@SEDECALUSA.COM Phone: (847) 3946960

Related Public Records

Same Entity

SEDECAL S.A.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3006972752 Stephanix La Ricamarie Auvergne-Rhone-Alpes, FR
3011347852 A.T.S. Applicazione Tecnologie Speciali s.r.l. Torre de Roveri Bergamo, IT
9617251 SEDECAL S.A. ALGETE Madrid (Province), ES

Similar Registrations

Registration Number Establishment Name Location
3023003446 BLOCK IMAGING SAS Weyersheim Bas-Rhin, FR
3005172103 DRTECH Corporation Seongnam-si Gyeonggi, KR
3010703925 MAKAR CONSULTING PTY LTD Belrose New South Wales, AU
3015276088 CAN TECHNOMED TRADING LTD. Richmond British Columbia, CA
3031503890 BLOCK IMAGING PARTS & SERVICE Holt, MI, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009868110. Last updated year: 2026. Please use registration number 3009868110 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.