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Green X 12 SE PHT-40CHS

by Vatech Co., Ltd. 2 variants

Model PHT-75CHS

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

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number88000164PHT75CHS08525 Basic UDI-DI 08800016401936UDI-DIDate7 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800016401936 UDI-DI Date1 Jun 2026ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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
Green X 12 SE (Smart Plus FL) EUDAMED
Green X 12 SE GUDID
Generic Name
Stationary panoramic/tomographic dental x-ray system, digital
Device Name
Computed Tomography X-ray System
Model / Reference
PHT-75CHS EUDAMED
PHT-40CHS GUDID
Primary DI / UDI-DI
08800016401936
Basic UDI-DI
88000164PHT75CHS08525
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 market of registration
Czechia
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
PHT-75CHS
GUDID
PHT-40CHS
Device ClassEUDAMED
Class IIb
GUDID
Class II

Other devices from Vatech Co., Ltd.

See all devices from Vatech Co., Ltd. →

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No