FOCUS™ Pro
by PaloDEx Group Oy 3 variants
Part of a family of 6 devices: see the family page
Ref 901326-PTUModel Focus / FNX-1
FOCUS™ Pro (901326-PTU) is a Class IIb device made by PaloDEx Group Oy, registered in EUDAMED on 15 Sep 2026 (Basic UDI-DI 643003587IntraTHAC9), active as of 7 Nov 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number643003587IntraTHAC9 06430035875252 | Date15 Sep 2026 | StatusActive |
Official records
- EUDAMED public site 643003587IntraTHAC9
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- Focus™
- Model / reference
- Focus / FNX-1, 901326-PTU
- Primary DI / UDI-DI
- 06430035875252
- Basic UDI-DI
- 643003587IntraTHAC9
- EMDN code
- Z1103040101 Equipment for conventional endoral radiology
- Device class
- Class IIb
- EU registration type
- Standard device
- EU market of registration
- Finland
Manufacturer details
- EUDAMED SRN
- FI-MF-000004943
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