NExT-AS

FDA UDI

Class II (US FDA UDI)

by Eb Neuro Spa

Identity

Trade Name: NExT-AS FDA UDI
Generic Name: Electromyograph FDA UDI
Device Name: Acoustic stimulation earphones FDA UDI
Model / Reference: B9109000141 FDA UDI
Description: Acoustic stimulation earphones FDA UDI

Identifiers

Primary DI / UDI-DI: 08056446901199 FDA UDI
510(k) Number: K242832 FDA UDI
FDA Product Code: GWL FDA UDI
OLT FDA UDI
IKN FDA UDI
GWE FDA UDI
GWF FDA UDI
GWJ FDA UDI
GMDN Term: Electromyograph FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.1835 FDA UDI
882.1400 FDA UDI
890.1375 FDA UDI
882.1890 FDA UDI
882.1870 FDA UDI
882.1900 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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

Yes

FDA UDI

Category: Electromyograph Evoked-potential graphic recording system

NExT-AS by Eb Neuro Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K242832 also covers:

Flash Led Stimulator — EB NEURO SPA
GOGGLES STIMULATOR II — EB NEURO SPA
Isolation Transformer ‘GP’ 110-120 VAC 50/60 Hz — EB NEURO SPA
NExT-AMP — EB NEURO SPA
NExT-AMP-ADVANCED — EB NEURO SPA
NExT-DOCKING — EB NEURO SPA
NExT-HS — EB NEURO SPA
NExT-PAD — EB NEURO SPA

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: Eb Neuro Spa

Sources (1)

FDA UDI 70cdc908-1fa1-4860-ae53-97cb8b6d9f95 35 fields · synced May 30, 2026