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Dhx-70H 1

by DigiMed Co., Ltd.

Ref DMC-12Model xm-lite

Dhx-70H 1 is a diagnostic x-ray system generator (EU MDR Class IIb; FDA Class II; FDA product code EHD, Unit, X-Ray, Extraoral With Timer) made by DigiMed Co., Ltd., registered in EUDAMED on 9 Sep 2026 (Basic UDI-DI 880002181X2P3C4H55) and listed in FDA GUDID since 12 Jun 2024 (UDI-DI 08800021800137), active as of 12 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 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number880002181X2P3C4H55 Basic UDI-DI 08800021800137UDI-DIDate9 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800021800137 UDI-DI Date12 Jun 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 880002181X2P3C4H55 registered 9 Sep 2026 Active
  • FDA GUDID UDI-DI 08800021800137 listed 12 Jun 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08800021800137
  2. Registered EUDAMED 880002181X2P3C4H55

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  • Withdrawn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
Dhx-70H
Generic name
Diagnostic x-ray system generator, portable
Model / reference
xm-lite EUDAMED
DMC-12 EUDAMED
1 GUDID
Primary DI / UDI-DI
08800021800137
Basic UDI-DI
880002181X2P3C4H55
Direct marketing DI
08800021800137
FDA product code
EHD
EMDN code
Z1103040102 Equipment for digital endoral radiology
GMDN term
Diagnostic x-ray system generator, portable
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
872.1800
EU registration type
Standard device
EU market of registration
Portugal
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
xm-lite
DMC-12
GUDID
1
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: Diagnostic x-ray system generator, portable

Similar devices in this category

Other devices filed under EQUIPMENT FOR DIGITAL ENDORAL RADIOLOGY.

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Properties

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