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NeMus 2

FDA UDI

Class II (US FDA UDI)

by Eb Neuro Spa

Identity

Trade Name
NeMus 2 FDA UDI
Generic Name
Evoked-potential graphic recording system FDA UDI
Device Name
EEG/EMG/EP Amplifier FDA UDI
Model / Reference
B9700066010 FDA UDI
Description
EEG/EMG/EP Amplifier FDA UDI

Identifiers

Primary DI / UDI-DI
08056446900376 FDA UDI
510(k) Number
K133517 FDA UDI
FDA Product Code
GWJ FDA UDI
GWF FDA UDI
GWE FDA UDI
GWL FDA UDI
GMDN Term
Evoked-potential graphic recording system FDA UDI

Classification

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

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: ElectromyographEvoked-potential graphic recording system

NeMus 2 by Eb Neuro Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Evoked-potential graphic recording system.

Cleared under the same submission

K133517 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Eb Neuro Spa

Sources (1)

  • FDA UDI fc1701b4-73cd-4df1-a7d9-8eb812a8571f 35 fields · synced May 30, 2026