NeuroPlex E128 Sterile

FDA UDI

Class II (US FDA UDI)

by Blackrock Microsystems

Identity

Trade Name: NeuroPlex E128 Sterile FDA UDI
Generic Name: Electroencephalographic signal amplifier FDA UDI
Device Name: Sterile NeuroPlex E128: PN-12890 (Replacing PN-10907) FDA UDI
Model / Reference: 12890 FDA UDI
Description: Sterile NeuroPlex E128: PN-12890 (Replacing PN-10907) FDA UDI

Identifiers

Catalog Number: 12890 FDA UDI
Primary DI / UDI-DI: 00814901021480 FDA UDI
510(k) Number: K202174 FDA UDI
FDA Product Code: GWL FDA UDI
GWK FDA UDI
GMDN Term: Electroencephalographic signal amplifier FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.1835 FDA UDI
882.1845 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Electroencephalographic signal amplifier

NeuroPlex E128 Sterile by Blackrock Microsystems — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K202174 also covers:

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: Blackrock Microsystems

Sources (1)

FDA UDI 20e77204-bff7-4eb4-80e4-c807be3e5e11 35 fields · synced Jun 6, 2026