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Planmed Oy

Active in EUDAMED

Finlandfrom SRN EUDAMED FDA SRN FI-MF-000006837 FEI 3002807903

Planmed Oy is a medical device manufacturer based in Finland, with 24 devices listed in FDA 510(k), EUDAMED and FDA GUDID (FDA Class II; EU Class IIb) as of 14 Nov 2026.

Devices
24
Registrations
EUDAMEDFDA
FDA recalls
0

Registry facts

Counted by deviCERTS from registry records, 14 Nov 2026

Registries
  • FDA 510(k) 14
  • EUDAMED 7
  • FDA GUDID 5

A device listed in two registries counts in both.

Device classes
  • FDA Class II 17
  • EU Class IIb 7
Top EMDN categories
Identifiers
  • EUDAMED SRN FI-MF-000006837
  • FDA FEI 3002807903
  • DUNS 459718193

At a glance

Counted by deviCERTS from registry records

EU certificates

2 of 2 in force.

See certificates

Market reach

European Union
EUDAMED actor, 2 certificates
United States
FDA FEI

What Planmed Oy makes

Planmed Oy manufactures electromagnetic surgical navigation device tracking systems and limited-view-field CT systems, including products such as Planmed Cytoguide, Planmed Sophie and Sophie Classic mammographic X-ray units, Planmed Nuance Digiguide, Planmed Clarity 2D and Clarity S, and mobile Sophie modifications.

The company's devices are classified as Class II and Class IIb and are listed in regulatory registries including Eudamed, FDA 510(k), and FDA UDI. Planmed Oy is based in Finland (FI).

AI-generated from registry data, 5 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue24

Newest first, rows 1-24 of 24

Search and filter all 24 devices
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  • Planmed Nuance Excel

    Withdrawn Registry: GUDID Class:II

  • Planmed Sophie Classic

    Withdrawn Registry: GUDID Class:II

  • Planmed Verity

    Listed Registry: GUDID Class:II

  • Planmed Cytoguide Ref K973493

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Planmed Sophie & Planned Sophie Classic Ref K983659

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Planmed Nuance Digiguide Ref K121963

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Planned Sophied Classic Ref K962105

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Planmed Clarity 2D and Clarity S Ref K192317

    Active Regimes: CE MDR CE MDD 510(k) Registry: 510(k) Class:II

  • Planmed Sophie Mammographic X-Ray Unit Ref K951883

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Planmed Sophie And Sophie Classic Ref K991826

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Planmed Sophie & Sophie Classic (With Digispot And Cytoguide) Ref K021945

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Planmed Sophie Nuance Classic Ref K042671

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Mobile Sophie Modification Ref K934373

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Planmed Cytoguide Ref K923471

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Planmed Sophie & Planmed Sophie Classic Ref K013656

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Planmed Sophie, Planmed Sophie Classic Ref K010116

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Planmed Clarity 2D, Planmed Clarify S Ref K211720

    Active Regimes: CE MDR CE MDD 510(k) Registry: 510(k) Class:II

  • Planmed Clarity+ Ref 30063790

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Planmed XFI Ref 30022041

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:IIb

  • Planmed Verity Ref 30010465

    Active Regimes: CE MDR 510(k) Registry: EUDAMED Class:IIb

  • SCS Medseries H22 Ref 30046641

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Planmed Clarity Ref 20009418

    Active Regimes: 510(k) CE MDD, withdrawn Registry: EUDAMEDGUDID Class:IIb

  • SCS MedSeries® H50 Ref FE005364

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Planmed ClarityGuide Ref 20009947

    Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED Class:IIb

Rows 1-24 of 24

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
FI-MF-000006837
FDA FEI number
3002807903
DUNS number
459718193
EU VAT number
FI06887853
EUDAMED status
Active
EUDAMED registered name
Planmed Oy
Registered address
7, Sorvaajankatu, 00880, Helsinki, Finland
PRRC contact
Vesa Vahtila(public in EUDAMED)

EUDAMED certificates2

2 certificates2 valid, 0 expiredMDR 2next expiry 23 Jan 2027

EUDAMED certificates (2)

SGS FIMKO OY 0598 2 certificates

  • FI23/0000004 Active Reissued

    Quality management system EU MDR

    Issued
    5 Aug 2025
    Expires
    4 Aug 2029
  • FI23/0000004 Expiring Supplemented Expires in 70 days

    Quality management system EU MDR

    Issued
    13 Feb 2024
    Expires
    23 Jan 2027
    Reason
    Change approved

Frequently asked questions

How many devices does Planmed Oy have in the registry?

The registry currently lists 24 devices for Planmed Oy. Devices recorded under merged duplicate company entries are counted once.

Which registries list Planmed Oy's devices?

Among its 24 most recently registered devices, Planmed Oy has devices listed in EUDAMED (7 devices), FDA 510(k) (14 devices) and FDA GUDID (5 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Planmed Oy's devices fall under?

Among its 24 most recently registered devices, the classes recorded for Planmed Oy's devices are Class IIb and Class II. Each device page shows its own class and authorisation.

What EUDAMED certificates are recorded for Planmed Oy?

EUDAMED lists 2 certificates for Planmed Oy (quality management system) under MDR. The most recent was issued on 5 Aug 2025.

What are the newest devices from Planmed Oy in the registry?

The most recently registered devices listed for Planmed Oy include Planmed Nuance Excel, Planmed Sophie Classic, Planmed Verity and PLANMED CYTOGUIDE.

Generated automatically from registry data and not verified by a human reviewer.