# CAIs Sensor

> Active: European Union. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/cais-sensor-cais-ifu-001>
- Manufacturer: [BrainU Co., Ltd.](https://devicerts.com/manufacturers/brainu-co-ltd) (South Korea)
- Device class: Class I (EU MDR)
- EMDN: N0101020101 EEG CORTICAL ELECTRODES

## Registrations and authorizations

- **EUDAMED** · CE/MDR · European Union · Basic UDI-DI 88001313CAIs-001EW · UDI-DI 08800131300015 · registered 2026-07-01 · status: Active
- **EUDAMED** · CE/MDR · European Union · 2026-MDR/QS-040 · issued 2026-06-29 · expires 2031-06-29 · status: Active

## EU certificates

- 2026-MDR/QS-040 · Quality management system · MDR · notified body 3EC International a.s. · issued 2026-06-29 · expires 2031-06-29 · status: issued

## Recalls

No recall on record.

## Identity

- Model / reference: CAIS-001 [EUDAMED]; CAIS-IFU-001 [EUDAMED]

## Identifiers

- Primary DI / UDI-DI: 08800131300015 [EUDAMED]
- Basic UDI-DI: 88001313CAIs-001EW [EUDAMED]
- EMDN code: N0101020101 [EUDAMED]

## Classification

- Device class: Class I [EUDAMED]
- System or procedure pack: System which is a device in itself [EUDAMED]
- EU registration type: Standard device [EUDAMED]
- EU market of registration: Greece [EUDAMED]

## Properties

- Measuring function: Yes [EUDAMED]
- Supplied sterile: No [EUDAMED]
- Sterilise before use: No [EUDAMED]
- Implantable: No [EUDAMED]
- Reusable: No [EUDAMED]
- Contains latex: No [EUDAMED]
- Reprocessed single-use device: No [EUDAMED]
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No [EUDAMED]
- Incorporates a substance derived from human blood or plasma: No [EUDAMED]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- Contains endocrine-disrupting substances: No [EUDAMED]
- Administering medicine: No [EUDAMED]
- Incorporates a medicinal substance: No [EUDAMED]

## Source and citation

- Cite as: CAIs Sensor, BrainU Co., Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/cais-sensor-cais-ifu-001 (data as of 2026-11-14).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed)
- Registry records last synced: 2026-10-24
- Statuses computed as of: 2026-11-14
- JSON: <https://devicerts.com/devices/cais-sensor-cais-ifu-001.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/cais-sensor-cais-ifu-001
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.