Facility

SPES MEDICA S.P.A

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3005581220
Establishment type	Export Device to the United States But Perform No Other Operation on Device; Manufacture Medical Device
Location	VIA EUROPA-ZONA INDUSTRIALE BATTIPAGLIA Salerno, IT 84091
Registration status	Active · expires 2026
Parent company	Spes Medica S.p.A. (owner-operator 9082762)
Brand names	Spes Media Subdermal Needle Electrodes

Activity by year

Recalls (1)

Devices registered here (1)

Electrode, Needle
Product code GXZ (opens in a new tab) · Class II · Neurology · 21 CFR 882.1350

Recalls & enforcement

Class IITerminated2021-04-08
The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.

All facilities operated by Spes Medica S.p.A.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “SPES MEDICA S.P.A (FEI 3005581220) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3005581220-spes-medica-s-p-a/

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