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Codman® Holter®

by Integra LifeSciences Production Corporation United States EUDAMED

Ref 821644

EMDN N01038099

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-10381780517870 Basic UDI-DIDate11 Sep 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

Model / Reference
821644
Primary DI / UDI-DI
10381780517870
Basic UDI-DI
B-10381780517870
EMDN Code
N01038099 Intracranial drainage devices and kits - accessories - other
Device Class
Class III
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
US-MF-000009189
Authorised representative
Integra LifeSciences Services FR-AR-000002474

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Implantable
Other properties (11)
  • 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 10381780517870|B-10381780517870 61 fields · synced 24 Oct 2026