← Back to catalogue
CAI Monitoring System
EUDAMEDClass IIb (EU MDR)
Ref IFU-01Model CAI Monitoring System
Identity
- Trade Name
- CAI Monitoring System EUDAMED
- Device Name
- Depth of Anesthesia Monitoring System EUDAMED
- Model / Reference
- CAI Monitoring System EUDAMEDIFU-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800131300008 EUDAMED
- Basic UDI-DI
- B-08800131300008 EUDAMED
- EMDN Code
- V0399 MEASUREMENT DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
CAI Monitoring System by BrainU Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08800131300008 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- BrainU Co., Ltd.
- EUDAMED SRN
- KR-MF-000033438
- Authorised Representative
- Meridius Medical Europe Limited IE-AR-000004258
Sources (1)
- EUDAMED bed4f547-574a-4616-a521-289b619921ae 61 fields · synced Jun 19, 2026