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Data Analysis Software
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref SW23380N
by Megin Oy
Identity
- Trade Name
- Data analysis software 3.4 FDA UDI
- Generic Name
- Electroencephalograph FDA UDI
- Device Name
- Data Analysis Software EUDAMEDA comprehensive analysis suite for magnetoencephalographic and electroencephalographic data acquired with Elekta Neuromag®, Elekta Neuromag® TRIUX and TRIUX™ neo. FDA UDI
- Model / Reference
- SW23380N EUDAMEDFDA UDI
- Description
- A comprehensive analysis suite for magnetoencephalographic and electroencephalographic data acquired with Elekta Neuromag®, Elekta Neuromag® TRIUX and TRIUX™ neo. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06430056480022 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06430056480022 EUDAMED
- FDA Product Code
- OLX FDA UDI
- EMDN Code
- Z12101292 MAGNETOENCEPHALOGRAPHY INSTRUMENTS – MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Electroencephalograph FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1400 FDA UDI
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Data Analysis Software by Megin Oy — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06430056480022 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Megin Oy
- EUDAMED SRN
- FI-MF-000011965
Sources (2)
- EUDAMED a526e7bd-cad6-44c1-ab61-55c1e6c84423 61 fields · synced Jun 18, 2026
- FDA UDI d6889373-2161-403e-9729-171506c75e61 33 fields · synced May 30, 2026