Is this your brand? Sign in to claim ownership.

Planmed Oy

Finland·FI-MF-000006837

Last updated September 17, 2026

Information

Device	Model / Reference	Registries	Class	Status
Planmed	Nuance Excel	FDA UDI	Class II	Unknown
Planmed	Sophie Classic	FDA UDI	Class II	Unknown
Planmed	Verity	FDA UDI	Class II	Active
Planmed Cytoguide	K973493	FDA 510(k)	Class II	Active
Planmed Sophie & Planned Sophie Classic	K983659	FDA 510(k)	Class II	Active
Planmed Nuance Digiguide	K121963	FDA 510(k)	Class II	Active
Planned Sophied Classic	K962105	FDA 510(k)	Class II	Active
Planmed Clarity 2D and Clarity S	K192317	FDA 510(k)	Class II	Active
Planmed Sophie Mammographic X-Ray Unit	K951883	FDA 510(k)	Class II	Active
Planmed Sophie And Sophie Classic	K991826	FDA 510(k)	Class II	Active
Planmed Sophie & Sophie Classic (with Digispot And Cytoguide)	K021945	FDA 510(k)	Class II	Active
Planmed Sophie Nuance Classic	K042671	FDA 510(k)	Class II	Active
Mobile Sophie Modification	K934373	FDA 510(k)	Class II	Active
Planmed Cytoguide	K923471	FDA 510(k)	Class II	Active
Planmed Sophie & Planmed Sophie Classic	K013656	FDA 510(k)	Class II	Active
Planmed Sophie, Planmed Sophie Classic	K010116	FDA 510(k)	Class II	Active
Planmed Clarity 2D, Planmed Clarify S	K211720	FDA 510(k)	Class II	Active
Planmed Clarity+	30063790	EUDAMED	Class IIb	Active
Planmed XFI	30022041	EUDAMED	Class IIb	Active
Planmed Verity	30010465	EUDAMED	Class IIb	Active
SCS Medseries H22	30046641	EUDAMED	Class IIb	Active
Planmed Clarity	20009418	EUDAMEDFDA UDI	Class IIb	Active
SCS MedSeries® H50	FE005364	EUDAMED	Class IIb	Active
Planmed ClarityGuide	20009947	EUDAMED	Class IIb	Active

No authorised representatives on record.

Not available yet.

Not available yet.

Not available yet.