Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9680895

FEI Number

3004839934

Entity Name

RALCO S.R.L.

City/State/Country

Biassono Monza e Brianza, IT

Establishment Address

VIA DEI TIGLI 13G, Biassono Monza e Brianza 20853, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

RALCO S.R.L. (Owner Number: 9012196)

Owner / Operator Contact Address

VIA DEI TIGLI 13G, --, BIASSONO, MI, IT-MB 20853, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K083029

PMA Number

N/A

All Registered Proprietary Names

R 221 ACS R 221 ACS DHHS R 302 DMLP DHHS R 302/A DHHS R 225 DHHS R 302 L/A DHHS R 221/A DHHS R 302 P 232 DHHS R 221 R 302 DMLP DHHS R 302 ACS/A DHHS R 302 DACS/A R 302 DACS/A DHHS R 302 MLP/A DHHS R 806 Q DHHS R 806 Q R 605 DASM DHHS R 225 ACS R 104/A R 605 DASM P 313/A R 108/237A/F R 302 MLP/A R 302/144/A R 302 DACS R 806 ASFL

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KPW	Device, Beam Limiting, X-Ray, Diagnostic	Radiology	Class 2	892.1610	2010-09-21
IZW	Collimator, Automatic, Radiographic	Radiology	Class 2	892.1610	2007-12-10
IZW	Collimator, Automatic, Radiographic	Radiology	Class 2	892.1610	2011-04-11

Official Correspondent

No official correspondent registered.

US Agent Details

Daniel Kamm Business: Kamm & Associates Email: fda.help.now@gmail.com Phone: (847) 3741727

Related Public Records

Same Entity

RALCO S.R.L.

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 9680895. Last updated year: 2026. Please use registration number 9680895 when referencing this establishment in official correspondence.