Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013488369

FEI Number

3013488369

Entity Name

SBM SISTEMI SRL

City/State/Country

Rivalta di Torino, IT

Establishment Address

via Coazze 4, Rivalta di Torino 10040, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SBM SISTEMI SRL (Owner Number: 10054993)

Owner / Operator Contact Address

via Coazze 4, Rivalta di Torino, IT-TO 10040, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

OS1000 ES600X TDEX ES600 APOLLO 1 OS1000X TDE ICP OSA TEARSCOPE SLIT LAMP ICP MGD SLIT LAMP PLUS IDRA HDA-100 TFA DSLC 200 DEM 100 DRY EYE SCAN ICP IOL ICP ACTIVA MED

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MMQ	Topographer, Corneal, Ac-Powered	Ophthalmic	Class 1	886.1350	2022-07-27
KYT	Light, Examination, Medical, Battery Powered	General Hospital	Class 1	880.6350	2017-05-23
HLG	Pupillometer, Ac-Powered	Ophthalmic	Class 1	886.1700	2017-05-23
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2022-04-29

Official Correspondent

Matteo Barberis

US Agent Details

Katie Doane Business: Pragmatic Compliance dba FDAbasics Email: usagent@fdabasics.com Phone: (716) 7750533

Related Public Records

Same Entity

SBM SISTEMI SRL

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K881862	Thermo Body Wrap Systems, Inc.	THERMO-BODY-WRAP SYSTEM	1988-10-13

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3003288808	WAVELIGHT GmbH	PRESSATH Bavaria, DE
9611269	OCULUS OPTIKGERATE GMBH	WETZLAR Hesse, DE
1000391004	KEELER LTD.	WINDSOR, BERKSHIRE Windsor and Maidenhead, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013488369. Last updated year: 2026. Please use registration number 3013488369 when referencing this establishment in official correspondence.