Skip to content

Endodontic Stainless Steel Hand Files

by Diadent Group International

Ref HEDSTROM FILES 21mm #8 / SS503-101

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 Number88063835EIF3J Basic UDI-DI 08806383537025UDI-DIDate6 May 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  • Withdrawn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
Endodontic Instruments
Model / Reference
HEDSTROM FILES 21mm #8 / SS503-101
Primary DI / UDI-DI
08806383537025
Basic UDI-DI
88063835EIF3J
EMDN Code
L159004 Endodontic rasps and files, reusable
Device Class
Class I
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
KR-MF-000023806
Authorised representative
Diadent Europe B.V. NL-AR-000012597

Other devices from Diadent Group International

See all devices from Diadent Group International →

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