Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9616258

FEI Number

3003310735

Entity Name

DIVEL ITALIA SPA

City/State/Country

Calderara di Reno (BO) Emilia-Romagna, IT

Establishment Address

DIVEL ITALIA SPA, Via Verde 5/A, Calderara di Reno (BO) Emilia-Romagna 40012, IT

Establishment Type(s)

Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

DIVEL ITALIA SPA UNIPERSONALE (Owner Number: 10054078)

Owner / Operator Contact Address

DIVEL ITALIA SPA UNIPERSONALE, Via Verde 5/A, Calderara di Reno (BO), IT-45 40012, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HQG	Lens, Spectacle, Non-Custom (Prescription)	Ophthalmic	Class 1	886.5844	2017-02-08

Official Correspondent

valentina biasizzo

US Agent Details

Lisa Wright Business: THE VISION COUNCIL Email: lwright@thevisioncouncil.org Phone: (703) 5484560

Related Public Records

Same Entity

DIVEL ITALIA SPA UNIPERSONALE

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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3007675955	Carl Zeiss Vision Canada, Inc.	Toronto Ontario, CA
1000428458	GKB OPHTHALMICS LIMITED - UNIT II	North Goa Goa, IN
3038136215	MEIVISION (VIETNAM) CO., LTD	Ho Chi Minh City, VN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9616258. Last updated year: 2026. Please use registration number 9616258 when referencing this establishment in official correspondence.