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DMAX Coloring Liquid 2M1-30ml

by DMAX Co., Ltd.

Ref 2M1-30ml

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

CE MDR

Valid until

4 Mar 2031

CE MDR certificate

FDA recalls

None found

in data synced 22 Oct 2026

Documents

1 certificate

Certifier SGS Belgium NV

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberKR26/00000032 Date4 Mar 2026IssuedStatusActive expires 4 Mar 2031
United StatesGUDID listing GUDID Number08809542035400 UDI-DI Date24 May 2019ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • KR26/00000032 Active

    Quality management system EU MDR

    Certifier
    SGS Belgium NV 1639
    Issued
    4 Mar 2026
    Expires
    4 Mar 2031

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
DMAX Coloring Liquid 2M1-30ml EUDAMED
DMAX / Confident / Chang's / CAMeleon Coloring Liquid GUDID
Generic name
Dental appliance fabrication material, ceramic
Device name
Liquid Stain for dental zirconium prosthesis
Model / reference
2M1-30ml
Primary DI / UDI-DI
08809542035400
Basic UDI-DI
880954203LD00FP
510(k) Number
FDA product code
EIH
EMDN code
Q010699 Materials for the preparation of custom-made dental devices - other
GMDN term
Dental appliance fabrication material, ceramic
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.6660
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
KR-MF-000020635
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from DMAX Co., Ltd.

See all devices from DMAX Co., Ltd. →

Properties

  • Prescription use
  • Lot / batch number
  • Expiration date

Other properties (22)

  • Supplied sterile: No
  • Sterilise before use: No
  • Single use: No
  • Implantable: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Manufacturing date: No