3-Pt Head Mask Bluefix 2mm Micro
by Orfit Industries 2 variants
Ref 35773BF/2MI/EModel Mask
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number5420028700595K 05420028767962 | Date6 Oct 2026 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- Raycast® High Precision – Bluefix
- Model / reference
- Mask, 35773BF/2MI/E
- Primary DI / UDI-DI
- 05420028767962
- Basic UDI-DI
- 5420028700595K
- EMDN code
- V0804 PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)
- Device class
- Class I
- EU registration type
- Standard device
- EU market of registration
- Belgium
Manufacturer details
- EUDAMED SRN
- BE-MF-000007872
Other devices from Orfit Industries
Properties
Other properties (14)
- Supplied sterile: No
- Sterilise before use: No
- Implantable: No
- Reusable: No
- Contains latex: No
- Reprocessed single-use device: No
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
- Incorporates a substance derived from human blood or plasma: No
- Contains human tissues or cells: No
- Contains animal tissues or cells: No
- Contains endocrine-disrupting substances: No
- Administering medicine: No
- Measuring function: No
- Incorporates a medicinal substance: No