MR Conditional Disposable EEG Cup Electrode

FDA UDI

Class II (US FDA UDI)

by Spes Medica Spa

Identity

Trade Name: MR Conditional Disposable EEG Cup Electrode FDA UDI
Generic Name: Analytical scalp electrode, single-use FDA UDI
Model / Reference: DCPEX-21S FDA UDI

Identifiers

Primary DI / UDI-DI: 08054655034738 FDA UDI
FDA Product Code: GXY FDA UDI
GMDN Term: Analytical scalp electrode, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.1320 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Analytical scalp electrode, single-use

MR Conditional Disposable EEG Cup Electrode by Spes Medica Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Zeto ONE Short-Term Electrode Set — ZETO INC · Class II
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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Spes Medica Spa

Sources (1)

FDA UDI a9969cb5-9651-4aed-a9aa-4a377ad6872c 32 fields · synced Jun 1, 2026