Skip to content

BIONIKA TH, Fejcsavar, technikai

by BIONIKA Medline Kft. EUDAMED

Active European Union

Ref 626.082.014.000

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number599322001SV Basic UDI-DIDate20 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Device Name
Dental laboratory devices, Class I.
Model / Reference
626.082.014.000
Primary DI / UDI-DI
05993220862952
Basic UDI-DI
599322001SV
EMDN Code
Q010280 Prosthetic dentistry devices - accessories
Device Class
Class I
Market of Registration
Hungary

Manufacturer details

EUDAMED SRN
HU-MF-000004631

Other devices from BIONIKA Medline Kft.

See all devices from BIONIKA Medline Kft. →

Properties

  • Reusable

Other properties (12)

  • Sterile: No
  • Implantable: 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