Orfit Industries 29102
Ref 29102Model Base Plate, Cover, Post, Cushion, Mask
Orfit Industries 29102 is a device classified as Class I in the EU and Class II in the US made by Orfit Industries NV, registered in EUDAMED on 24 Sep 2026 (Basic UDI-DI 5420028700504Z) and listed in FDA GUDID since 7 Dec 2022 (UDI-DI 05420028755020), active as of 25 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number5420028700504Z 05420028755020 | Date24 Sep 2026 | StatusActive |
| United States | GUDID listing GUDID | Number05420028755020 | Date7 Dec 2022 | StatusListed |
Official records
- EUDAMED public site 5420028700504Z
- AccessGUDID record 05420028755020
Across registries
- EUDAMED Basic UDI-DI 5420028700504Z registered 24 Sep 2026 Active
- FDA GUDID UDI-DI 05420028755020 listed 7 Dec 2022 Listed
Timeline
- Listed FDA GUDID 05420028755020
- Registered EUDAMED 5420028700504Z
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- ORFIT MRI-S Solution Head, Neck & Shoulders EUDAMEDOrfit Industries GUDID
- Generic name
- DNA-based tissue typing IVD, reagent
- Device name
- Orfit® MRI-S Solution for brain, head and neck
- Model / reference
- 29102, Base Plate, Cover, Post, Cushion, Mask
- Primary DI / UDI-DI
- 05420028755020
- Basic UDI-DI
- 5420028700504Z
- FDA product code
- IYE
- EMDN code
- Z11010180 Linear accelerators - hardware accessories
- GMDN term
- DNA-based tissue typing IVD, reagent
- Device class
- Class I EUDAMEDClass II GUDID
- Regulation number
- 892.5050
- EU registration type
- Standard device
- EU market of registration
- Belgium
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Safe
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device class | Class I | Class II |
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