Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010398215

FEI Number

3010398215

Entity Name

MANIFATTURA CI-ZETA SRL

City/State/Country

Passirano Brescia, IT

Establishment Address

via Luigi Fassati, 11, Passirano Brescia 25050, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Manifattura CI-ZETA Srl (Owner Number: 10086429)

Owner / Operator Contact Address

via Luigi Fassati, 11, Passirano, IT-BS 25050, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CzSalus CzSalus

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LLK	Legging, Compression, Non-Inflatable	General Hospital	Class 2	880.5780	2022-11-09
MDR	Binder, Medical, Therapeutic	General Hospital	Class 1	880.5160	2022-11-09

Official Correspondent

Ferdinando Zanola

US Agent Details

Lucio Miranda Business: ExportUSA New York Corp Email: claudio@exportusa.us Phone: (718) 5225575

Related Public Records

Same Entity

Manifattura CI-ZETA Srl

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 3010398215. Last updated year: 2026. Please use registration number 3010398215 when referencing this establishment in official correspondence.