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Matrixes

by FKG Dentaire Sàrl 18 variants

Ref 04.201.00.015.ACModel 04.200.00.015.AC

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

Overview

Matrixes is a cutting-edge medical device that provides precise and accurate measurements for dental procedures. Developed in compliance with industry standards, this device ensures the highest level of sterility and safety for patients.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number7640142410101008N Basic UDI-DI 07640142422006UDI-DIDate16 Jan 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  • Withdrawn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

Model / Reference
04.200.00.015.AC, 04.201.00.015.AC
Primary DI / UDI-DI
07640142422006
Basic UDI-DI
7640142410101008N
EMDN Code
Q01010401 Paper and gutta-percha tips, matrices and wedges for dentistry
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CH-MF-000017925
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from FKG Dentaire Sàrl

See all devices from FKG Dentaire Sàrl →

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