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Aspen, Richard-Allan, Secureline

by Aspen Surgical Products, Inc. United States EUDAMED

Ref 19004-03CE EMDN V9004

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0840113240000ST4C Basic UDI-DIDate15 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Surgical Marking Pens (sterile)
Model / Reference
19004-03CE
Primary DI / UDI-DI
00840113231409
Basic UDI-DI
0840113240000ST4C
EMDN Code
V9004 Skin marking dermographic pencils and pens
Device Class
Class I
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000008255
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Aspen Surgical Products, Inc.

See all devices from Aspen Surgical Products, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (12)
  • 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 00840113231409|0840113240000ST4C 61 fields · synced 24 Oct 2026