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PaX-i Plus PCH-30CS

by Vatech Co., Ltd.

Model PCH-30CS

PaX-i Plus PCH-30CS is a medical device (EU MDR Class IIb; FDA Class II; FDA product code MUH, System,X-Ray,Extraoral Source,Digital; EMDN category equipment for extraoral dental radiology) made by Vatech Co., Ltd., registered in EUDAMED on 4 Sep 2026 (Basic UDI-DI 88000164PCH30CS070X3) and listed in FDA GUDID since 30 Jun 2017 (UDI-DI 08800016400427), active as of 23 Oct 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number88000164PCH30CS070X3 Basic UDI-DI Date4 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800016400427 UDI-DI Date30 Jun 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 88000164PCH30CS070X3 registered 4 Sep 2026 Active
  • FDA GUDID UDI-DI 08800016400427 listed 30 Jun 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08800016400427
  2. Registered EUDAMED 88000164PCH30CS070X3

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  • Withdrawn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
PaX-i Plus
Generic name
Stationary panoramic/tomographic dental x-ray system, digital
Model / reference
PCH-30CS
Primary DI / UDI-DI
08800016400427, 08800016400434
Basic UDI-DI
88000164PCH30CS070X3
FDA product code
MUH
EMDN code
Z1103030102 Equipment for extraoral dental radiology, digital
GMDN term
Stationary panoramic/tomographic 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
Czechia
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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.

Related devices

Category: Stationary panoramic/tomographic dental x-ray system, digital

Similar devices in this category

Other devices filed under EQUIPMENT FOR EXTRAORAL DENTAL RADIOLOGY, DIGITAL.

Other devices from Vatech Co., Ltd.

See all devices from Vatech Co., Ltd. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)