Identity
- Trade Name
- NeuroPlex E128 FDA UDI
- Generic Name
- Electroencephalographic signal amplifier FDA UDI
- Device Name
- Non-sterile NeuroPlex E128: PN-12889 (Replacing PN-10906) FDA UDI
- Model / Reference
- 12889 FDA UDI
- Description
- Non-sterile NeuroPlex E128: PN-12889 (Replacing PN-10906) FDA UDI
Identifiers
- Catalog Number
- 12889 FDA UDI
- Primary DI / UDI-DI
- 00814901021473 FDA UDI
- 510(k) Number
- K202174 FDA UDI
- FDA Product Code
- GWL FDA UDIGWK FDA UDI
- GMDN Term
- Electroencephalographic signal amplifier FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1835 FDA UDI882.1845 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electroencephalographic signal amplifier
NeuroPlex E128 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:
- Digital NeuroPort Biopotential Signal Processing System — Blackrock Microsystems
- Digital NeuroPort Biopotential Signal Processing System — Blackrock Microsystems
- Digital NeuroPort Biopotential Signal Processing System — Blackrock Microsystems
- Digital NeuroPort Biopotential Signal Processing System — Blackrock Microsystems
- Digital NeuroPort Biopotential Signal Processing System — Blackrock Microsystems
- Digital NeuroPort Biopotential Signal Processing System — Blackrock Microsystems
- Digital NeuroPort Biopotential Signal Processing System — Blackrock Microsystems
- Digital NeuroPort Biopotential Signal Processing System — Blackrock Microsystems
- Digital NeuroPort Biopotential Signal Processing System — Blackrock Microsystems
- Digital NeuroPort Biopotential Signal Processing System — Blackrock Microsystems
- Digital NeuroPort Biopotential Signal Processing System — Blackrock Microsystems
- NeuroPlex E128 Sterile — Blackrock Microsystems
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 095e1fad-8c5b-4ce7-bb4d-006c0ec6981c 35 fields · synced May 30, 2026