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Agilon®

by implantcast GmbH Germany EUDAMED

Ref 78000101Model SH12TMCINST

EMDN L091199

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number4048844SH12TMCINST84 Basic UDI-DIDate13 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
-
Model / Reference
SH12TMCINST, 78000101
Primary DI / UDI-DI
04048844203573
Basic UDI-DI
4048844SH12TMCINST84
Direct Marketing DI
04048844203573
EMDN Code
L091199 Orthopaedic prosthetics instruments, reusable - other
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000010002

Other devices from implantcast GmbH

See all devices from implantcast GmbH →

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED 04048844203573|4048844SH12TMCINST84 61 fields · synced 24 Oct 2026