Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005581220

FEI Number

3005581220

Entity Name

SPES MEDICA S.P.A

City/State/Country

BATTIPAGLIA Salerno, IT

Establishment Address

VIA EUROPA-ZONA INDUSTRIALE, BATTIPAGLIA Salerno 84091, IT

Establishment Type(s)

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

Owner / Operator

Spes Medica S.p.A. (Owner Number: 9082762)

Owner / Operator Contact Address

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

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K192603

PMA Number

N/A

All Registered Proprietary Names

Disposable Adhesive Surface Electrodes DryTouch Suction Stimulator Spes Media Subdermal Needle Electrodes

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2006-02-06
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2021-12-08
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2012-06-15
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2014-12-02
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2019-02-26
GXZ	Electrode, Needle	Neurology	Class 2	882.1350	2019-12-02

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

Spes Medica S.p.A.

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
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0023-2020	Stryker Instruments Div. of Stryker Corporation	2	C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.
Z-0024-2020	Stryker Instruments Div. of Stryker Corporation	2	C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.

Similar Registrations

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3004695199	INCEREB LTD	Dublin Dun Laoghaire-Rathdown, IE
9616086	DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.	TIJUANA Baja California, MX
3012316249	COMPASS HEALTH BRANDS (CORPORATE OFFICE)	Middleburg Heights, OH, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005581220. Last updated year: 2026. Please use registration number 3005581220 when referencing this establishment in official correspondence.