Eu Mdd
Eu Md Class 2b
On The Market
🇰🇷 South Korea
CAI Monitoring System
Devices (same UDI-DI)
1
Certificates
1
Countries
1
Notified Bodies
1
Basic Information
- Primary DI
- 08800131300008
- Basic UDI-DI Code
- B-08800131300008
- Reference
- IFU-01
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2b
- Status
- On The Market
- Manufacturer
- BrainU Co.,Ltd.
Additional Description
CAI Monitoring System is a system providing patient’s consciousness level through their brainwave analysis during surgical procedure to medical staffs, and the system comprises with CAIs (brainwave sensor), CAIx (amplification module), CAIv monitor and algorithms for calculation and analysis. CAI Monitoring System, which has capability of setting various conditions, is designed to monitor anesthetic state of brain by collecting and analyzing brainwaves.
CND Nomenclature Codes
| Code | Description |
|---|---|
| V0399 | MEASUREMENT DEVICES - OTHER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 2021-MDD/QS-008 | 3EC International a.s. | Expired |
Available In Countries
🇬🇷 Greece
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