Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004985762

FEI Number

3004985762

Entity Name

BETAFARMA S.P.A

City/State/Country

Milan Lombardy, IT

Establishment Address

Via Enrico De Nicola,10, Cesano Boscone, Milan Lombardy 20090, IT

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Betafarma S.p.A (Owner Number: 10090690)

Owner / Operator Contact Address

Via Enrico De Nicola,10, Cesano Boscone, Milan, IT-25 20090, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Gengigel Hydrogel 300ml Gengigel Spray 20ml Gengigel Hydrogel 150ml Gengigel Gel 20ml Gengigel Gel Junior 15ml

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OLR	Oral Wound Dressing	Unknown	Class U	N/A	2024-04-29

Official Correspondent

No official correspondent registered.

US Agent Details

James Martin Biggs Business: GBM Authorized Representative Ltd. Email: regulatory@ricerfarma.com Phone: (405) 7771033

Related Public Records

Same Entity

Betafarma 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 3004985762. Last updated year: 2026. Please use registration number 3004985762 when referencing this establishment in official correspondence.