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Dmc-07

by DIGIMED Co., Ltd.

Ref DMC-07Model MINIX-S

Dmc-07 is a hand-held intraoral dental x-ray system (EU MDD Class IIb; FDA Class II; FDA product code EHD, Unit, X-Ray, Extraoral With Timer) made by DigiMed Co., Ltd., registered in EUDAMED on 14 Oct 2024 (Basic UDI-DI B-08800021800021) and listed in FDA GUDID since 19 Jan 2018 (UDI-DI 08800021800021), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08800021800021 Basic UDI-DI 08800021800021UDI-DIDate14 Oct 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number08800021800021 UDI-DI Date19 Jan 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08800021800021 registered 14 Oct 2024 Active
  • FDA GUDID UDI-DI 08800021800021 listed 19 Jan 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08800021800021
  2. Registered EUDAMED B-08800021800021

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  • Withdrawn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
MiniX-S
Generic name
Hand-held intraoral dental x-ray system, digital
Model / Ref / Catalog
MINIX-S EUDAMED
DMC-07 EUDAMED
1 GUDID
Primary DI / UDI-DI
08800021800021
Basic UDI-DI
B-08800021800021
FDA product code
EHD
EMDN code
Z1103040102 Equipment for digital endoral radiology
GMDN term
Hand-held intraoral dental x-ray system, digital
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
872.1800
EU registration type
Legacy device (under a directive)
EU market of registration
Portugal
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
MINIX-S
DMC-07
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.

Manufacturer details

EUDAMED SRN
KR-MF-000016608
Authorised representative
KTR Europe GmbH DE-AR-000005685

Related devices

Category: Dental digital imaging sensor, intraoral

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 (20, all answered No)