4PTS Head Neck&Shoulders Mask Bluefix 2mm Micro
by Orfit Industries EUDAMED
Active
Ref 35764BF/2MIModel Mask
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number5420028700595K | Date6 Oct 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- Withdrawn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
- Raycast® High Precision – Bluefix
- Model / Reference
- Mask, 35764BF/2MI
- Primary DI / UDI-DI
- 05420028752456
- Basic UDI-DI
- 5420028700595K
- EMDN Code
- V0804 PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)
- Device Class
- Class I
- Market of Registration
- Belgium
Manufacturer details
- EUDAMED SRN
- BE-MF-000007872
Other devices from Orfit Industries
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