Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011534533

FEI Number

3011534533

Entity Name

SPES MEDICA S.P.A

City/State/Country

Genova Liguria, IT

Establishment Address

Via Buccari 21, Genova Liguria 16153, IT

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Registrar Corp (Owner Number: 10088094)

Owner / Operator Contact Address

Via Buccari 21, Genova, IT-NOTA 16153, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K212326

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
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2023-05-24
KOY	Degreaser, Skin, Surgical	General, Plastic Surgery	Class 1	878.4730	2023-05-24
GYB	Media, Electroconductive	Neurology	Class 2	882.1275	2023-05-24

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Registrar Corp

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3017422354	EMI (DONGGUAN) ASIA LIMITED	Dongguan City Guangdong, CN
9616139	CHEMIGLAS CORP.	Yangsan Gyeongnam, KR
3007034808	Barber of Sheffield Ltd	Barnsley, South Yorkshire, GB

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K070612	Top-Rank Health Care Equipment Co., Ltd.	TOP-RANK ADHESIVE ELECTRODE	2007-05-07
K123915	Grass Technologies, an Astro-Med, Inc. Product Gro	DE48-PLUS	2013-04-24
K073532	Technomed Europe	DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES	2008-05-01
K260363	Ceribell, Inc.	Ceribell Brain Monitor Headband	2026-04-03
K091762	Covidien	DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE	2009-12-22

Similar Registrations

Registration Number	Establishment Name	Location
3015614098	CGX, LLC	San Diego, CA, US
3015429360	SHAOXING YINGTUO HEALTHCARE CO.,LTD.	Shaoxing Zhejiang, CN
3004695199	INCEREB LTD	Dublin Dun Laoghaire-Rathdown, IE
3005581220	SPES MEDICA S.P.A	BATTIPAGLIA Salerno, IT
9616086	DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.	TIJUANA Baja California, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011534533. Last updated year: 2026. Please use registration number 3011534533 when referencing this establishment in official correspondence.