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Planmeca Oy

Active in EUDAMED

Finlandfrom SRN EUDAMED FDA SRN FI-MF-000006499 FEI 1000207287

Planmeca Oy is a medical device manufacturer based in Finland, with 70 devices listed in EUDAMED, FDA GUDID and FDA 510(k) (FDA Class II; EU Class IIb, I and IIa) as of 13 Nov 2026.

Devices
70
Registrations
EUDAMEDFDA
FDA recalls
0

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • EUDAMED 37
  • FDA GUDID 32
  • FDA 510(k) 19

A device listed in two registries counts in both.

Device classes
  • FDA Class II 28
  • EU Class IIb 18
  • EU Class I 10
  • EU Class IIa 8
  • FDA Class I 6
Top EMDN categories
Identifiers
  • EUDAMED SRN FI-MF-000006499
  • FDA FEI 1000207287
  • DUNS 368788568

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 Planmeca Oy makes

Planmeca Oy manufactures digital stationary panoramic and tomographic dental X-ray systems, including intraoral digital imaging sensors and associated software applications for panoramic imaging. Their portfolio includes standalone panoramic X-ray units, such as the Planmeca ProMax and Viso series, as well as delivery systems for dental imaging and software tools like Romexis for image processing and management.

The company’s devices are regulated under EU Medical Device Regulations (Class I, IIa, IIb) and FDA classifications (510(k) and UDI-listed). Their products are recorded in the EUDAMED database, FDA’s 510(k) premarket notifications, and FDA’s UDI system, reflecting compliance with both European and US regulatory frameworks. The manufacturer is based in Finland.

AI-generated from registry data, 1 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue70

Newest first, rows 1-50 of 70

Search and filter all 70 devices
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  • Planmeca Pro40 Ref 30056969

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Planmeca Onyx 1

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:II

  • Planmeca Pro50 S Ref 30064300

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Planmeca ProMax ProMax 3D Max

    Withdrawn Registry: GUDID Class:II

  • Planmeca Sovereign Classic

    Withdrawn Registry: GUDID Class:I

  • Planmeca Chair

    Withdrawn Registry: GUDID Class:I

  • Planmeca ProMax ProMax 3D

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

  • Planmeca ProMax ProMax 3D Plus

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

  • Planmeca Viso G5

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

  • Planmeca ProMax ProMax 3D Mid

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

  • Planmeca Viso G7

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

  • Planmeca ProMax ProMax 3D Max

    Withdrawn Registry: GUDID Class:II

  • Planmeca Romexis 4

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

  • Planmeca ProMax ProMax 3D

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

  • Planmeca ProMax ProMax 3D

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

  • Planmeca ProMax ProMax 3D Max

    Withdrawn Registry: GUDID Class:II

  • Planmeca ProMax ProMax 2D

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

  • Planmeca Emerald S Ref 30018474

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Planmeca Emerald Ref 30006359

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Planmeca Compact i5 Ref 30013450

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • Planmeca Viso 2D Classic Ref 30051739

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • KaVo ProXam 2D Ref 30038581

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Planmeca Olo Ref 10033200

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • KaVo ProXam iX Ref 30038579

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Planmeca Pro50 Chair Ref 30011796

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Pm 2002 Cc Proline Ref K970812

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

  • Dixi 2 Ref K000428

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

  • Planmeca Intracam Ref K972033

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

  • Promax, Panoramic X-Ray Unit With Cephalostat Ref K011619

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

  • Prostyle Intra Ref K970975

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

  • Pm 2002 Proline/Aec Ref K000163

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

  • Prostyle Compact Ref K961420

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

  • Planmeca ProMax 3D Max, Planmeca Maximity Ref K160506

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

  • Dimex 2 Ref K000454

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

  • Prostyle Compact Ref K963209

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

  • Planmeca Dixi, Digital Intraoral X-Ray Imaging System Ref K980581

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

  • Pm 2002 Cc Proline Ref K970263

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

  • Planmeca Intracam Station Ref K984013

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

  • Panoramic X-Ray Units, Modification Ref K934063

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

  • Planmeca Promax 3D Max Ref K093590

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

  • Panoramic X-Ray Unit (Modification) Ref K952763

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

  • Planmeca Promax With Dec (Dynamic Exposure Control) Ref K051464

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

  • Prostyle Intra Ref K955429

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

  • Dimax 2 Ref K000771

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

  • Planmeca SingLED Ref 10020815

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Planmeca ProMax Ref 30003108

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIb

  • Planmeca Solanna Ref 30009016

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Planmeca Lumo Ref 10033600

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Planmeca ProOne Ref 30010469

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

  • Planmeca Imprex Ref 30031809

    Active Regimes: CE MDR Registry: EUDAMED Class:I

Rows 1-50 of 70

Showing 1-50 of 70

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
FI-MF-000006499
FDA FEI number
1000207287
DUNS number
368788568
EU VAT number
FI01127732
EUDAMED status
Active
EUDAMED registered name
Planmeca Oy
Registered address
6, Asentajankatu, 08800, Helsinki, Finland
PRRC contact
Tuomas Jurvanen(public in EUDAMED)

EUDAMED certificates2

2 certificates2 valid, 0 expiredMDR 2next expiry 27 Dec 2028

EUDAMED certificates (2)

SGS FIMKO OY 0598 2 certificates

  • FI23/00000059 Active Supplemented

    Quality management system EU MDR

    Issued
    17 Sep 2025
    Expires
    26 Jun 2030
    Reason
    Other
  • FI23/00000059 Active Supplemented

    Quality management system EU MDR

    Issued
    7 Mar 2025
    Expires
    27 Dec 2028
    Reason
    Add device or group

Frequently asked questions

How many devices does Planmeca Oy have in the registry?

The registry currently lists 70 devices for Planmeca Oy. Devices recorded under merged duplicate company entries are counted once.

Which registries list Planmeca Oy's devices?

Among its 50 most recently registered devices, Planmeca Oy has devices listed in EUDAMED (17 devices), FDA 510(k) (19 devices) and FDA GUDID (21 devices). A device can be listed in more than one registry, so these counts overlap.

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

Among its 50 most recently registered devices, the classes recorded for Planmeca Oy's devices are Class I, Class IIa, Class IIb and Class II. Each device page shows its own class and authorisation.

What EUDAMED certificates are recorded for Planmeca Oy?

EUDAMED lists 2 certificates for Planmeca Oy (quality management system) under MDR. The most recent was issued on 17 Sep 2025.

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

The most recently registered devices listed for Planmeca Oy include Planmeca Pro40, Planmeca Onyx 1, Planmeca Pro50 S and Planmeca ProMax ProMax 3D Max.

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