Identity
- Trade Name
- MaxFilter™ EUDAMEDMaxFilter™ 2.2 FDA UDI
- Generic Name
- Magnetoencephalography system, superconducting FDA UDI
- Device Name
- MaxFilter™ Software EUDAMEDMaxFilter™ is used with Elekta Neuromag®, Elekta Neuromag® TRIUX and TRIUXTM neo in suppressing magnetic interference and in reducing measurement artifacts. FDA UDI
- Model / Reference
- SW24051N EUDAMEDFDA UDI
- Description
- MaxFilter™ is used with Elekta Neuromag®, Elekta Neuromag® TRIUX and TRIUXTM neo in suppressing magnetic interference and in reducing measurement artifacts. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06430056480039 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06430056480039 EUDAMED
- 510(k) Number
- K233985 FDA UDI
- FDA Product Code
- OLY FDA UDI
- EMDN Code
- Z12101292 MAGNETOENCEPHALOGRAPHY INSTRUMENTS – MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Magnetoencephalography system, superconducting 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
MaxFilter™ 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-06430056480039 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Megin Oy
- EUDAMED SRN
- FI-MF-000011965
Sources (2)
- EUDAMED 18cbb0bb-d83b-485e-8b6b-24f95396efab 61 fields · synced Jul 15, 2026
- FDA UDI 002b7661-5de8-4c5a-92e7-cad90fddc973 34 fields · synced May 30, 2026