Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009061550

FEI Number

3009061550

Entity Name

RIMSA P. LONGONI SRL

City/State/Country

Seregno Monza e Brianza, IT

Establishment Address

via Monterosa 18, Seregno Monza e Brianza 20831, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

RIMSA P. LONGONI SRL (Owner Number: 10034162)

Owner / Operator Contact Address

Via Monterosa 18, Seregno, IT-MB 20831, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PENTA63N+63N DOUBLE CEILING SURGICAL LIGHT AND ACCESSORIES PENTA63NSO CEILING SURGICAL LIGHT AND ACCESSORIES PENTA63N+30N DOUBLE CEILING SURGICAL LIGHT AND ACCESSORIES UNICA 520 CUPOLA OF SURGICAL LIGHT AND ACCESSORIES UNICA 520 CUPOLA OF SURGICAL LIGHT WITH CAMERA PREDISPOSITION AND ACCESSORIES Z400601 CUPOLA OF SURGICAL LIGHT WITH CAMERA PREDISPOSITION AND ACCESSORIES Z400600 CUPOLA OF SURGICAL LIGHT AND ACCESSORIES U29 CUPOLA OF SURGICAL LIGHT WITH CAMERA PREDISPOSITION AND ACCESSORIES U29 CUPOLA OF SURGICAL LIGHT AND ACCESSORIES Z401700 CUPOLA OF SURGICAL LIGHT AND ACCESSORIES Z401701 CUPOLA OF SURGICAL LIGHT WITH CAMERA PREDISPOSITION AND ACCESSORIES DE12 Z400613 CAMERA FOR DoVera DM520 AND U29 STERILIZABLE HANDLE FOR VARIOUS MODELS OF SURGICAL LIGHTS, PART NO. Z400307-4, Z400349-4, Z400460-4, Z180045, Z180045-1

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FSY	Light, Surgical, Ceiling Mounted	General, Plastic Surgery	Class 2	878.4580	2018-07-18
KZF	Device, Medical Examination, Ac Powered	General Hospital	Class 1	880.6320	2010-11-11
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2018-07-26
FTA	Light, Surgical, Accessories	General, Plastic Surgery	Class 2	878.4580	2020-10-01

Official Correspondent

Carlo Longoni

US Agent Details

Silvia Tamarri Business: THEMA CORP Email: usreg@complifegroup.com Phone: (215) 8459459

Related Public Records

Same Entity

RIMSA P. LONGONI 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
K780666	Castle Co.	DAYSTAR SELECTRA & SELECTRA/ORBITER	1978-04-27
K851742	Burton Medical Products Corp.	MEDICAL EXAMINATION LIGHTS	1985-05-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0028-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800091, Sterile, LD0692 - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0029-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800401, Sterile, GS0470 - Lap Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0030-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800407, Sterile, OR0476 - Ortho Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROI, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0031-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800408, Sterile, LD0477 - C-Section Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROI, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0032-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800409, Sterile, GS0478 - LAP Chole Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009061550. Last updated year: 2026. Please use registration number 3009061550 when referencing this establishment in official correspondence.