Identity
- Trade Name
- Micromed FDA UDI
- Generic Name
- Bioelectrical signal analysis software FDA UDI
- Device Name
- BRAIN QUICK SOFTWARE EUDAMEDsoftware for acquisition, review, storage , process and measure of biologic signals (particularly EEG and PSG) FDA UDI
- Model / Reference
- BRAIN QUICK SOFTWARE EUDAMEDFDA UDI
- Description
- software for acquisition, review, storage , process and measure of biologic signals (particularly EEG and PSG) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08033928120958 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08033928120958 EUDAMED
- 510(k) Number
- K000963 FDA UDI
- FDA Product Code
- GWE FDA UDIOLT FDA UDIGWF FDA UDIGWQ FDA UDI
- EMDN Code
- Z12109082 VARIOUS NEUROLOGY AND NEUROSURGERY INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- Bioelectrical signal analysis software FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1890 FDA UDI882.1400 FDA UDI882.1870 FDA UDI
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- Italy 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
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
Brain Quick Software by Micromed S.p.A. — Class IIb — 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-08033928120958 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Micromed S.p.A.
- EUDAMED SRN
- IT-MF-000009983
Sources (2)
- EUDAMED 438cfbcf-73c3-4991-9291-18c23173ed61 61 fields · synced Jun 18, 2026
- FDA UDI ec443bc5-582b-4ee2-8eea-fe82666e58f5 34 fields · synced May 30, 2026