waveguard original
by eemagine Medical Imaging Solutions GmbH EUDAMED
Active
Ref CA-212Model CA-xxx/CY-xxx/CS-xxx/NA-xxx/NG-xxx/XC-xxx/XE-xxx/XS-xxx
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number++B195waveguard9J | Date12 May 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- waveguard product family
- Model / Reference
- CA-xxx/CY-xxx/CS-xxx/NA-xxx/NG-xxx/XC-xxx/XE-xxx/XS-xxx, CA-212
- Primary DI / UDI-DI
- +B195CA212
- Basic UDI-DI
- ++B195waveguard9J
- Direct Marketing DI
- +B195CA212
- EMDN Code
- N01010203 EEG headsets
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000005560
Other devices from Eemagine Medical Imaging Solutions GmbH
See all devices from Eemagine Medical Imaging Solutions GmbH →
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No