Skip to content

vatech A9 PHT-30CSS

by Vatech Co., Ltd.

Model PHT-30CSS

vatech A9 PHT-30CSS is a medical device (EU MDD Class IIb; FDA Class II; FDA product code OAS, X-Ray, Tomography, Computed, Dental; EMDN category computed tomographs - not exceeding 2 layers) made by Vatech Co., Ltd., registered in EUDAMED on 27 Aug 2026 (Basic UDI-DI B-08800016401097) and listed in FDA GUDID since 21 Jun 2021 (UDI-DI 08800016401103), active as of 25 Oct 2026.

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

CE MDD

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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08800016401097 Basic UDI-DI Date27 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800016401103 UDI-DI Date21 Jun 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08800016401097 registered 27 Aug 2026 Active
  • FDA GUDID UDI-DI 08800016401103 listed 21 Jun 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08800016401103
  2. Registered EUDAMED B-08800016401097

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
vatech A9
Generic name
Stationary panoramic/tomographic dental x-ray system, digital
Model / reference
PHT-30CSS
Description
Dental Computed Tomography X-ray System functioning Pano/CT/CEPH Image Acquisition Xmaru1404CF-Plus, Xmaru2602CF
Dental Computed Tomography X-ray System functioning Pano/CT Image Acquisition Xmaru1404CF-Plus
Primary DI / UDI-DI
08800016401103, 08800016401097
Basic UDI-DI
B-08800016401097, B-08800016401103
FDA product code
OAS
EMDN code
Z11030601 Computed tomographs - not exceeding 2 layers
GMDN term
Stationary panoramic/tomographic dental x-ray system, digital
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.1750
EU registration type
Legacy device (under a directive)
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 COMPUTED TOMOGRAPHS (CT).

Other devices from Vatech Co., Ltd.

See all devices from Vatech Co., Ltd. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)