Identity
- Trade Name
- N-EEGX FDA UDI
- Generic Name
- Patient monitoring system module, electroencephalographic FDA UDI
- Device Name
- N-EEGX MJS101, N-EEGX HEADBOX ASSEMBLY USA FDA UDI
- Model / Reference
- MJS101 FDA UDI
- Description
- N-EEGX MJS101, N-EEGX HEADBOX ASSEMBLY USA FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00195278466679 FDA UDI
- 510(k) Number
- K191322 FDA UDI
- FDA Product Code
- OMC FDA UDIORT FDA UDIOLT FDA UDIMHX FDA UDIMLD FDA UDIGWJ FDA UDI
- GMDN Term
- Patient monitoring system module, electroencephalographic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1400 FDA UDI870.1025 FDA UDI882.1900 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
No
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
MR Unsafe FDA UDI
Category: Patient monitoring system module, electroencephalographic
N-Eegx by GE Healthcare Finland Oy — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K191322 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- GE Healthcare Finland Oy
Sources (2)
- FDA UDI 6bb8c197-6137-4336-8d37-3068cc703bd1 35 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 5, 2026