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Acrylic teeth Anis. Box with 120 anterior teeth

by Krk Ltd, trading as Anis-dent

Ref 00001

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number462014931an212009MA Basic UDI-DI 04620149310080UDI-DIDate3 Feb 2023RegisteredStatusActive

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  • Withdrawn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
Acrylic teeth Anis
Model / Reference
00001
Primary DI / UDI-DI
04620149310080
Basic UDI-DI
462014931an212009MA
Direct Marketing DI
04620149310080
EMDN Code
Q01020601 Mobile dental prostheses
Device Class
Class I
EU market of registration
Bulgaria

Manufacturer details

EUDAMED SRN
RU-MF-000031945
Authorised representative
Advena Limited MT-AR-000000234

Related devices

Category: Partial denture

Other devices from Krk Ltd, trading as Anis-dent

See all devices from Krk Ltd, trading as Anis-dent →

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