Skip to content

Hydro Print Premium Regular Set

by Vigodent Indústria e Comércio Ltda

Ref 052327Model Alginato Odontológico para Moldagem

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number78978083ALG35863ZF Basic UDI-DI 07897808336669UDI-DIDate11 Feb 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Alginato Odontológico Premium – Hydro Print / Chroma Print / Ezact Kromm
Model / Reference
Alginato Odontológico para Moldagem, 052327
Primary DI / UDI-DI
07897808336669
Basic UDI-DI
78978083ALG35863ZF
EMDN Code
Q01020101 Dental impression alginates
Device Class
Class I
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
BR-MF-000051955
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Vigodent Indústria e Comércio Ltda

Properties

Other properties (13)

  • Sterile: 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