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Henry Schein Maxima

by Henry Schein Inc. United States EUDAMED

Ref 9889994Model TF-528 (HS)

EMDN L159004

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-10304040164447 Basic UDI-DIDate5 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Headstroemfile
Model / Reference
TF-528 (HS), 9889994
Primary DI / UDI-DI
10304040164447
Basic UDI-DI
B-10304040164447
EMDN Code
L159004 Endodontic rasps and files, reusable
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000021683
Authorised representative
Henry Schein Services GmbH DE-AR-000008001

Other devices from Henry Schein, Inc.

See all devices from Henry Schein, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Reusable
Other properties (11)
  • 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

Sources (1)

  • EUDAMED 10304040164447|B-10304040164447 61 fields · synced 24 Oct 2026