Skip to content

Planmeca ProX

by Planmeca Oy

Ref 10029551

Planmeca ProX (10029551) is a stationary intraoral dental x-ray system (EU MDR Class IIb; FDA Class II; FDA product code EHD, Unit, X-Ray, Extraoral With Timer) made by Planmeca Oy, registered in EUDAMED on 3 Jul 2024 (Basic UDI-DI 6430035420095V) and listed in FDA GUDID since 10 Aug 2016 (UDI-DI 06430035420360), active as of 7 Nov 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number6430035420095V Basic UDI-DI 06430035420360UDI-DIDate3 Jul 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number06430035420360 UDI-DI Date10 Aug 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 6430035420095V registered 3 Jul 2024 Active
  • FDA GUDID UDI-DI 06430035420360 listed 10 Aug 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 06430035420360
  2. Registered EUDAMED 6430035420095V

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Planmeca Intra
Generic name
Stationary intraoral dental x-ray system, digital
Model / Ref / Catalog
10029551, ProX, 30054728, 30054748, 30054749, 30054750, 30061112, 30061673
Primary DI / UDI-DI
06430035420360
Basic UDI-DI
6430035420095V, B-06430035420360
FDA product code
EHD
EMDN code
Z1103040101 Equipment for conventional endoral radiology
GMDN term
Stationary intraoral dental x-ray system, digital
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
872.1800
EU registration type
Standard device
Legacy device (under a directive)
EU market of registration
Finland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
10029551
GUDID
ProX
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 EQUIPMENT FOR CONVENTIONAL ENDORAL RADIOLOGY.

Other devices from Planmeca Oy

See all devices from Planmeca Oy →

Properties

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