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Shapedchords External

by ARKONA Laboratorium Farmakologii Stomatologicznej Grzegorz Kalbarczyk

Model Internal, External

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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number590443371TF0127B Basic UDI-DI 05903678494490UDI-DIDate10 Feb 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Shapedchords / Gąsienica
Model / Reference
Internal, External
Primary DI / UDI-DI
05903678494490
Basic UDI-DI
590443371TF0127B
EMDN Code
Q01010199 Dental restoration devices - other
Device Class
Class IIa
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000029550

Other devices from ARKONA Laboratorium Farmakologii Stomatologicznej Grzegorz Kalbarczyk

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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