Cranial 4Pi Headrest Inlay H&N
by Brainlab SE EUDAMED
Active
Ref 43448C
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number4056481Cranial4PiHeadShJ4 | Date5 Apr 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
- Cranial 4PI Headrest Inlays
- Model / Reference
- 43448C
- Primary DI / UDI-DI
- 04056481146818
- Basic UDI-DI
- 4056481Cranial4PiHeadShJ4
- Direct Marketing DI
- 04056481146818
- EMDN Code
- Z11019080 Various radiotherapy and radiosurgery instruments - hardware accessories
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000006183
Other devices from Brainlab SE
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