bossdevice MEDICAL
by sync2brain GmbH EUDAMED
Active
Ref M01
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number426245257bossdeviceMW | Date23 Sep 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- 1000238544 Issued
Quality management system EU MDR
- Notified body
- Notified body 0297
- Issued
- 16 Sep 2026
- Expires
- 15 Sep 2031
Specification
- Device Name
- bossdevice MEDICAL
- Model / Reference
- M01
- Primary DI / UDI-DI
- 04262452570296
- Basic UDI-DI
- 426245257bossdeviceMW
- Direct Marketing DI
- 04262452570296
- EMDN Code
- Z129099 Various instruments for functional exploration and therapeutic interventions - other
- Device Class
- Class IIa
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000027244
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