FDA UDI
In Commercial Distribution
🇺🇸 United States
cognitrace
DI: B195LC106
·
Model: LC-106
·
eemagine Medical Imaging Solutions GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- cognitrace
- Primary DI
- B195LC106
- Version / Model
- LC-106
- Company Name
- eemagine Medical Imaging Solutions GmbH
- Labeler DUNS
- 313152485
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-04-30
- Public Version
- 2
- Public Version Date
- 2025-10-01
- Public Version Status
- Update
- Public Device Record Key
- 883ec533-7c79-4e41-a78b-73aac58822b9
Device Description
cognitrace component
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GWQ | Full-montage Standard Electroencephalograph | Neurology | 882.1400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47541 | Bioelectrical signal analysis software | A software program intended to acquire, process, store and analyse biological electrical signals, both in real-time and delayed time, for diagnostic applications. The signals are typically provided by electrophysiological recording/monitoring [e.g., electromyography (EMG), electroencephalography (EEG), evoked potentials (EP), bioelectrical impedance analysis (BIA)]. It may be installed in the recording/monitoring device, personal computer, or data network server. It is neither intended for continuous bedside nor intraoperative monitoring, and is not dedicated to hearing analysis. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B195LC106 | HIBCC |
Customer Contacts
- Phone
- +493029048404
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K051825 | 000 |