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Planmeca ProMax

by Planmeca Oy 2 variants

Ref 30003108

Planmeca ProMax (30003108) is a device classified as Class IIb in the EU and Class II in the US made by Planmeca Oy, registered in EUDAMED on 3 Jul 2024 (Basic UDI-DI 6430035420165S) with CE/MDR certificate FI23/00000059 valid until 26 Jun 2030, cleared under FDA 510(k) K051464 on 24 Jun 2005 and listed in FDA GUDID since 19 Sep 2016 (UDI-DI 06430035420445), active as of 7 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

26 Jun 2030

CE MDR certificate

FDA recalls

None found

in data synced 7 Nov 2026

Documents

1 certificate

Certifier SGS FIMKO OY

510(k) K051464

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberFI23/00000059 Date17 Sep 2025IssuedStatusActive expires 26 Jun 2030
United StatesGUDID listing GUDID Number06430035420445 UDI-DI Date19 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK051464 Date24 Jun 2005DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 6430035420165S registered 3 Jul 2024 Active· +1 more in the status table
  • FDA 510(k) K051464 decided 24 Jun 2005 Active
  • FDA GUDID UDI-DI 06430035420445 listed 19 Sep 2016 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • FI23/00000059 Active Supplemented

    Quality management system EU MDR

    Certifier
    SGS FIMKO OY 0598
    Issued
    17 Sep 2025
    Expires
    26 Jun 2030
    Reason
    Other

Timeline

5 dated events

  1. Cleared FDA 510(k) K051464
  2. Listed FDA GUDID 06430035420445
  3. Registered EUDAMED 6430035420165S
  4. Certificate issued EUDAMED FI23/00000059
  5. Certificate expires EUDAMED FI23/00000059

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Generic name
Stationary panoramic dental x-ray system, digital
Model / Ref / Catalog
30003108, ProMax 2D, 30054723, 30064278, 30054724, 30054736, 30054737, 30054746
Primary DI / UDI-DI
06430035420445
Basic UDI-DI
6430035420165S
510(k) Number
FDA product code
MUH
EMDN code
Z11030380 Instruments for extraoral dental radiology - hardware accessories
GMDN term
Stationary panoramic dental x-ray system, digital
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
872.1800
EU registration type
Standard device
EU market of registration
Finland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
30003108
GUDID
ProMax 2D
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
FI-MF-000006499

Similar devices in this category

Other devices filed under INSTRUMENTS FOR EXTRAORAL DENTAL RADIOLOGY.

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Properties

  • Prescription use
  • Over-the-counter
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)