Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003311293

FEI Number

3003311293

Entity Name

Sigmar Italia S.P.A

City/State/Country

ALME Bergamo, IT

Establishment Address

VIA SOMBRENO, 11, ALME Bergamo 24011, IT

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

SIGMAR ITALIA S.P.A (Owner Number: 9080151)

Owner / Operator Contact Address

VIA SOMBRENO, 11, ALME, BERGAMO, IT-NOTA 24011, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Decapinol Oral Rinse Gengigel Mouthrinse Ricerfarma SRL Gengigel spray Ricerfarma SRL Gengigel gel Ricerfarma SRL Gengigel Prof gel Ricerfarma SRL Gengigel Prof Fluid Ricerfarma SRL Gengigel Junior Ricerfarma SRL

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NTO	Rinse, Oral, Antibacterial (By Physical Means)	Dental	Class 2	872.5580	2011-03-15
OLR	Oral Wound Dressing	Unknown	Class U	N/A	2014-06-09

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

SIGMAR ITALIA S.P.A

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 3003311293. Last updated year: 2026. Please use registration number 3003311293 when referencing this establishment in official correspondence.