3-points hybrid open face mask with small aperture, Eff 16MI - Nanor 12MI+
Ref 33800/16MI/12MI+NModel Mask
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number5420028700214S | Date6 Oct 2026 | StatusActive |
Certificates
No notified-body 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- Withdrawn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 - Efficast® Masks, Nanor Masks and Hybrid Masks with Nanor for Patient Immobilisation -Head, Neck and Shoulder
- Model / Reference
- Mask, 33800/16MI/12MI+N
- Primary DI / UDI-DI
- 05420028741290
- Basic UDI-DI
- 5420028700214S
- 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