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FOCUS™ Pro OpenMount™

by PaloDEx Group Oy

Part of a family of 6 devices: see the family page

Ref 901327-PTUModel Focus / FNX-1

FOCUS™ Pro OpenMount™ (901327-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 European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number643003587IntraTHAC9 Basic UDI-DI 06430035875269UDI-DIDate15 Sep 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Focus™
Model / reference
Focus / FNX-1, 901327-PTU
Primary DI / UDI-DI
06430035875269
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

Similar devices in this category

Other devices filed under EQUIPMENT FOR CONVENTIONAL ENDORAL RADIOLOGY.

Other devices from PaloDEx Group Oy

See all devices from PaloDEx Group Oy →

Properties

Other properties (14, all answered No)