Identity
- Trade Name
- AE-120A EEG Head Set FDA UDI
- Generic Name
- Electroencephalograph FDA UDI
- Device Name
- AE-120A Accessory Kit with belts and forehead pad FDA UDI
- Model / Reference
- YZ-003A4 FDA UDI
- Description
- AE-120A Accessory Kit with belts and forehead pad FDA UDI
Identifiers
- Catalog Number
- YZ-003A4 FDA UDI
- Primary DI / UDI-DI
- 04931921903582 FDA UDI
- FDA Product Code
- OMC FDA UDI
- GMDN Term
- Electroencephalograph FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1400 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electroencephalograph
AE-120A EEG Head Set by Nihon Kohden Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Zeto ONE Head Unit - Small — ZETO INC · Class II
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
- Nihon Kohden Corp.
Sources (1)
- FDA UDI b41a50b1-a2ff-4124-8c80-561c00f57b14 35 fields · synced Jun 6, 2026